approximately 91% of patients diagnosed with end stage renal disease ( esrd ) choose to perform hemodialysis as treatment ( 1 ) . however , hemodialysis has many complications during and after the dialysis process ( 2 ) . mortality in patients undergoing hemodialysis has been reported as 16% according to the latest statistics , which often occurs following hemodialysis complications ( 3 ) . according to the association for the support of kidney patients report , from a total of 40000 patients with kidney complications , over 15000 undergo hemodialysis and about 1500 cases die due to the disease symptoms ( 1 ) , complications such as hypotension , headache , chest pain , etc . each year , of which hypotension is the most common acute complication in hemodialysis , occurring in 20 - 30% of patients and causing problems such as nausea , vomiting and muscle cramps ( 4 ) . despite recent advances in hemodialysis , in addition to being painful , this condition leads to restriction of patient movements ( 6 ) , increased levels of serum creatine phosphokinase , shortened effective time of dialysis ( 7 ) , and thus , increased mortality rate of patients ( 8) . approximately 42% of deaths in patients undergoing hemodialysis are due to cardiovascular complications ; the rate is three times higher than patients with non - uremic kidney complications . ischemia and the resulted cardiac arrhythmias and chest pain , hypotension and sudden death are among the cardiovascular complications during dialysis ( 9 ) . according to previous studies , the factors affecting the incidence of cardiovascular events during dialysis include hypotension , electrolyte and blood volume changes , inactivity , anemia , and poor diet ( 10 ) . on one hand , one of the concerns of patients with advanced and chronic renal failure is gastrointestinal complications , ranging from mild abdominal pain to severe gastrointestinal bleeding . however , the most common gastrointestinal symptoms during hemodialysis are nausea and vomiting with higher prevalence is in patients undergoing hemodialysis than others , as now these patients are treated symptomatically ( 11 ) . headache is another acute complication of hemodialysis which is usually caused in patients with increased fluid volume due to increased speed of dialysis and hypotension ( 12 ) . the mentioned complications not only lead to fatigue and malaise during dialysis ( 13 ) , but may cause insufficient removal of excess fluids from the body ( 14 ) and increased need for nursing care for frequent checking on patient s condition , administrating fluids and medications , oxygen therapy , positioning , reducing the ultra - filtration , and finally discontinuing the dialysis earlier than the scheduled program ( 15 ) . inadequate dialysis can lead to increased disease symptoms , increased duration of hospitalization , reduced patient s quality of life , and increased imposing costs for patients , their families and the health system , while a well - scheduled dialysis with few or no complications , in addition to reducing the costs can have an essential role in increasing the quality of life and survival of the patients ( 4 ) . research has shown that hemodialysis complications occur mainly due to noncompliance with the treatment plan . in fact , poor adherence to the treatment plan will be associated with poor clinical outcomes ; therefore , education of patients with chronic renal failure is highly crucial ( 16 ) . nurses have the direct responsibility for the care of patients undergoing hemodialysis ; they are responsible for educating the patients and their families ( 17 ) . one of the main topics of the training is to follow the treatment plan ( 18 ) . given that the major factors affecting the clinical outcomes of patients with kidney failure occur outside of the health care system and in the home environment , family members who spend time with the patient at home play a role in care responsibilities and the patient s support ( 19 ) . positive effects of education are considered as one of the most important aspects of nursing activities ( 20 ) , according to what was mentioned and with regard to the researcher s experience in care of patients during hemodialysis . this study aimed to answer two hypotheses :  hypotension in family - centered groups of patients is less than patient - centered groups  and  muscle cramps in family - centered group are less than patient - centered groups  . the current study was a quasi - experimental clinical trial with registration number irct201204161599n17 , performed on patients treated with hemodialysis referred to imam khomeini and amir alam hospitals affiliated to tehran university of medical sciences between may 2012 and october 2012 . the sample size was determined by the following formula and confidence interval ( ci ) = 95% , and power of 80% ( in each group n = 30 ) ( equation 1 ) . the inclusion criteria of patients were as follows ; age from 18 to 65 years ; undergoing hemodialysis three times a week , each time for 3 - 4 hours ; history of chest pain or symptoms of headache , nausea or vomiting during the two weeks before the intervention , no cardiovascular , gastrointestinal and cerebral vascular diseases and not using cardiac , anti - headache , anti - nausea and anti - vomiting medications , and lack of uremia phase at the time of the research . during the study , if any patient was a kidney transplant candidate or faced with changes of food and pharmaceutical diets by the physician , was excluded from the study . the inclusion criteria of the active member of the family were as follows ; the main person with the highest participation in treatment issues and spending more time with the patient ( according to the patient s opinion ) , being literate . after conducting the administrative procedures and obtaining the approval of the university ethics committee , following the introduction and explaining the objectives of the research to the research units ( with eligibility criteria to enter the study ) , the informed consent form was obtained from each patient and the study was performed . before the beginning of the intervention , the patients blood pressures were taken and controlled for two consecutive weeks , three days per week and five times a day ( immediately before the start of dialysis , one hour , two hours , three hours after it , and the final hour of dialysis ) , using the observation check list for recording blood pressure ; with the first occurrence of hypotension in any of the above steps , the patient was enrolled . in this study , hypotension during dialysis was defined as the time that the systolic pressure of patient decreased more than 30% compared to predialysis or was less than 100 mmhg , or a diastolic pressure below 60 mmhg ( 21 , 22 ) . other complications were also recorded using the observation checklist for two weeks , three days per week and twice a day ( at the middle and final half hour of the dialysis ) , when most of the symptoms occurred ( 13 ) , and with the first occurrence of any of the above complications , the patient was included in the study . according to the international headache society , headaches during dialysis are once considered when they start during dialysis and end 24 hours later . therefore , education of both groups ( patient - centered and family - centered ) was conducted as individual face - to - face training with regard to the patient s training needs , in three areas of diet , exercise program and medication diet on patient s bed . in the patient - oriented group , the educational content was provided only to the patients individually , while in the family - centered group , in addition to the patient , one active member of the family attended to the training sessions . the educational content of each session is described in table 1 . at the end of the sessions , the pamphlet of each session the researcher s contact number was also given to the participants in case of any questions . in the second and fourth weeks after the intervention , the episodes of hypotension , muscle cramps , chest pain , headache , nausea and vomiting were re - evaluated in both groups . therefore , these factors were examined for a week , three days per week and two times a day ( in the middle and the final half hour of dialysis ) . the questionnaire consisted of two parts : individual information of patients ( demographic information ) and information about the disease . the observing checklist included hypertension , muscle cramps , chest pain , headache , nausea and vomiting with 50 questions . content validity method was used to determine the scientific validity of the researcher - made questionnaire . therefore , after reading the books , the scholarly new and the relevant articles , similar studies and internet searching as well as collecting the faculty and advisors opinions and comments , data collection toll was prepared . thereafter , it was presented to 10 faculty members of tehran university of medical sciences to determine the content validity . after collecting their feedbacks , modifying and suggested comments by the faculty members were applied by help of the advisors and the experts . in addition , content validity ratio ( cvr ) and content validity index ( cvi ) were measured . content validity index was determined with cvi score of waltz and bausell ( > 0.79 = appropriate item , 0.70 - 0.79 = needs to be revised , < 0.79 = unacceptable ) . the questionnaire reliability was estimated using cornbrash s alpha coefficient as 0.75 and the observation checklist reliability was confirmed by simultaneous observation and agreement factor of one . data were analyzed using spss software version 16 , statistical independent t - test , fisher s exact test and chi - square test . during the study , 30 subjects were included in each group and none were excluded . the mean age of patients in the patient - centered and the family - oriented groups were 47.41  10.31 and 48.16  9.21 , respectively . other demographic characteristics are listed in table 2 .   abbreviation : df , degree of freedom . the two groups were similar regarding the demographic variables , except for marital status and lifestyle , which were not associated with compliance based on the independent t - test and were not considered interventional ( association of marital status with dieting : p = 0.49 ; medicinal : p = 0.11 ; motor ( movement ) : p = 0.49 ; the relationship between lifestyle and diet : p = 0.31 ; medicinal : p = 0.25 ; motor ( movement ) : p = 0.16 ) . diabetes was the major cause of dialysis factor in both patient - centered ( 43.3% ) and family - centered ( 43.3% ) groups ; most of the patients in both patient - centered ( 46.7% ) and family - centered ( 43.3% ) groups had been undergoing dialysis for one to five years . during the two weeks of the study before the intervention , the two groups had no significant differences regarding the frequency of hypotension with p = 0.91 and the mean change of 1.60 ( 1.30 ) as well as the frequency of muscle cramps with p = 0.50 and the mean change of 1.06 ( 1.01 ) . however , in the second and fourth weeks after the intervention , significant differences between the two groups were observed regarding the frequency of hypotension , respectively with p = 0.016 and the mean change of 0.70 ( 0.70 ) and p = 0.02 with the mean change of 0.86 ( 0.62 ) , muscle cramps with p = 0.01 and the mean change of 0.46 ( 0.86 ) and p = 0.02 with the mean change of 1 ( 1.05 ) . although hemodialysis administration in esrd patients is currently considered as the most common treatment method , it has numerous side effects on body organs , including the cardiovascular system , the nervous system and the gastrointestinal system and high mortality due to hemodialysis complications is still a serious problem ( 21 ) . the findings showed that within the two weeks of the study before the intervention in both groups , the highest frequently of hypotension was twice the highest hypotension occurred at the final hour of hemodialysis . therefore , the two groups were not significantly different in the frequency of hypotension and were homogeneous . however , in the second and fourth weeks after the intervention , education of patient associated with the active family member significantly reduced the frequency of hypotension . therefore , in the family - oriented group , in the second and fourth weeks after the intervention , respectively 73.3% and 63.3% of patients did not develop the mentioned complication , while in patient - centered group in the second and fourth weeks after the intervention , respectively 73.3% and 60% of the patients developed hypotension once . within the two weeks of the study before the intervention , the highest number of muscle cramps in both groups was once and the majority of cramps had occurred at the final half hour of hemodialysis . therefore , the two groups had no significant difference in the frequency of muscle cramps and were homogeneous . however , in the second and fourth weeks after the intervention , the education of patient associated with the active family member significantly reduced the frequency of muscle cramps , so that in the family - oriented group in the second and fourth weeks after the intervention , respectively 81.4% and 72.1% of the patients did not develop the complication , while in the patient - centered group in the second and fourth weeks after the intervention , respectively 60.3% and 60.3% of the patients developed muscle cramps once . in addition , the findings revealed that during the two weeks of the study before the intervention in both groups , the highest frequency of occurred chest pain and vomiting was once , while headaches and nausea occurred twice , all of which were often in the last half hour of hemodialysis . therefore , the two groups had no significant difference in the frequency of complications and were homogeneous . however , in the second and fourth weeks after the intervention , education of patient associated with the active family member significantly reduced the frequency of chest pain , headache , nausea and vomiting , so that in the family - oriented group in the second and fourth weeks after the intervention , the patients did not develop the complications as follows : 81.4% and 72.1% in chest pain episodes ; 58% and 63.3% in headache episodes ; 58% and 58% in nausea episodes ; and 81.4% and 72.1% in vomiting episodes ; while , in the patient - oriented group in the second and fourth weeks after the intervention , the situation of complications occurrence was as follows : chest pain : 60.3% ; headaches : 73.3% ; nausea : 46.6% ; vomiting : 60.3% . in a study by mottahedian tabrizi 17 ) , a checklist for recording the complications was used to examine the complications . they concluded that planned nursing care during dialysis significantly decreased nausea from 33.3% to 3.3% , reduced vomiting from 16.7% to zero with p < 0.02 , reduced muscle cramps from 50% to 6.7% with p = 0.001 , and decreased hypotension from 66.7% to 10% ( p < 0.001 ) . complications checklist was also used in the current study and the conducted family - centered training led to adherence to the treatment plan at home ( especially observing the fluid restriction ) and reduced the frequency of nausea , vomiting , muscle cramps and hypotension during the hemodialysis . lee and kim concluded that with proper training on nutrition in patients undergoing hemodialysis , gastrointestinal symptoms significantly improved and ultimately led to their improved quality of life ( p < 0.01 ) ( 23 ) . in the other study the importance of families to improve the quality of life of patients and their families , as well as the treatment outcomes were pointed out ( 24 ) . in a systematic review by luckett et al . the use of advanced care planning , including the use of family members in the treatment of patients with chronic kidney disease ( ckd ) due to their more knowledge of the care needs of the patient was recommended ( 25 ) . in the present study , with the active participation of families in teaching various issues , we tried to improve the clinical outcomes , including reducing the unpleasant side - effects during hemodialysis . in a study by sandra et al . it was concluded that families education and their participation in treatment led to a significant increase in adherence to the diet ( p = 0.04 ) and medication ( p = 0.029 ) plans ( 26 ) . in a systematic review by denhaerynck et al . 30 - 74% of patients had muscle cramps due to noncompliance with the treatment plan based on fluid restriction and dieting ( 27 ) . in the present study , we tried to investigate other common side - effects during hemodialysis with educating the health plan . in a study by setiani agus et al . ( 28 ) , the majority of patients undergoing hemodialysis developed hypophosphatemia ( 53.1% ) and needed to learn the proper use of their medications , especially phosphorus bonding agents , their significance , and effects of not using their medications . study ( 29 ) , it was found based on the statements of patients that they needed a source for protection and support and to become sensitive to follow the treatment plan and increase their knowledge in this regard ( 29 ) . according to the present study and the importance of compliance with treatment plan , as well as its impact on clinical outcomes in patients undergoing hemodialysis , it was tried with families attending and increasing their participation in treatment ; the rate of compliance with the treatment plan will be increased , and thereby , the common intradialytic complications would be reduced . at the end , according to the results , the percentage of hypotension in the family - centered group in the second and fourth weeks after the intervention was significantly lower than in the patient - centered group ( p = 0.016 and p = 0.02 , respectively ) . therefore , the first hypothesis of the study :  hypotension in the family - centered group is less than the patient - centered group  was accepted . furthermore , the percentage of muscle cramp in the family - centered group in the second and fourth weeks after the intervention was significantly lower than the patient - centered group ( p = 0.01 and p = 0.02 , respectively ) . therefore , the second hypothesis of the study :  muscle cramps in the family - centered group are less than the patient - centered group  was accepted . the questionnaires were filled through self - report ; thus , there were inaccuracies in recording of the data reported . in addition , different psychological and individual characteristics were effective on patients adherence to the treatment plan . the durations of control and follow - up were short ( four weeks ) ; thus , it is recommended to conduct a study with a larger sample size and a longer duration for better results . the questionnaires were filled through self - report ; thus , there were inaccuracies in recording of the data reported . in addition , different psychological and individual characteristics were effective on patients adherence to the treatment plan . the durations of control and follow - up were short ( four weeks ) ; thus , it is recommended to conduct a study with a larger sample size and a longer duration for better results .
background : poor adherence to treatment in patients undergoing hemodialysis leads to many complications , including death of the patient.objectives:this study was aimed to investigate the effect of family - based training on common side - effects during dialysis.patients and methods : the present randomized controlled trial study was conducted on 60 patients undergoing hemodialysis at hospitals of tehran university of medical sciences , iran , from may 2012 to october 2012 . 
 samples were randomly divided into two groups of patient - education ( n = 30 ) and education of patient associated with an active member of the family ( n = 30 ) . 
 blood pressure , chest pain , nausea , vomiting , headaches and muscle cramps were followed with a check list and a questionnaire . 
 the frequencies of the abovementioned complications at the mentioned intervals were recorded in three stages ( before the intervention as well as two and four weeks after the intervention ) . 
 data analysis was performed using spss software , version 16 , with chi - square test , fisher s exact test and independent t-test.results:the mean ages of the patients in patient - centered and the family - oriented groups were 47.41  10.31 and 48.16  9.21 , respectively . 
 the result showed that some of the variables such as chest pain ( p = 0.50 , p = 0.01 ) , nausea ( p = 0.50 , p = 0.01 ) , headache ( p = 0.81 , p = 0.016 ) , and blood pressure ( p = 0.91 , p = 0.016 ) were statistically significant before and four weeks after the intervention.conclusions:according to the result of this study , the presence of families in a treatment plan could be essential to follow the treatment plan and subsequently reduced the complications of hemodialysis .