## Protocol Section
### Identification Module
**NCT ID:** NCT06415188

**Brief Title:** The Effect of Therapeutic Play on Pain, Fear, Anxiety and Physiological Parameters and Parents' Satisfaction

**Official Title:** The Effect of Therapeutic Play on Pre-Treatment Pain, Fear, Anxiety and Physiological Parameters and Parents' Satisfaction

#### Organization Study ID Info
**ID:** SelcukUni2544
#### Organization
**Class:** OTHER
**Full Name:** Selcuk University
### Status Module
#### Completion Date
**Date:** 2024-05-10

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-10

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2024-04-15

**Type:** ACTUAL

#### Start Date
**Date:** 2023-05-15

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-10
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Selcuk University

#### Responsible Party

**Investigator Affiliation:** Selcuk University

**Investigator Full Name:** Sibel Küçükoğlu

**Investigator Title:** Prof

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** In this study, the effect of the therapeutic game applied before treatment on pain, fear, anxiety and physiological parameters and the satisfaction of the parents was investigated.

**Detailed Description:** Therapeutic play is defined as activities structured in accordance with children's age and development, or as a set of interventions to improve the well-being of children in the hospital environment. This method reduces the stress of illness or hospitalization, uses play as a means of self-expression and supports the development of positive coping mechanisms in pediatric patients. In the literature, it is seen that therapeutic play methods such as listening to music, drawing, reading stories, puppets, dolls, virtual reality tools, cartoon applications, watching videos and playing video games are used to reduce the child's pain and anxiety about invasive procedures. Studies conducted to reduce the interactions between children in the same environment during their treatment and care are quite limited. No study has been found to examine the effect of methods that jointly block/reduce vision and hearing during treatment and care on anxiety, fear and pain in children treated together in pediatric clinics.

### Conditions Module

**Conditions:**

- Child Behavior

- Pain, Acute

- Anxiety and Fear

**Keywords:**

- Pain

- anxiety

- children

- nursing

- therapeutic play

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** This study was conducted on children aged 3-6 years. The study was completed with a total of 40 children and parent pairs in the experimental and control groups. Simple randomization method was used in the study. The randomization table for which group the children would be in was made by an independent statistician. Letters A and B were used to represent the experimental and control groups. Which letter represented which group was determined by lottery. While therapeutic play intervention was applied in the experimental group, routine intervention was applied in the control group.

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 40

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Children in the experimental group received a therapeutic video game intervention in addition to the pre-treatment routine.

**Intervention Names:**

- Behavioral: Video game with headset

**Label:** Therapeutic play group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Children in the control group underwent routine clinical practice. No other intervention was performed.

**Label:** Control Group

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Therapeutic play group

**Description:** Half an hour before the first treatment in the morning, the screens around the patients' beds were closed by the researcher. The child was asked to choose one of the introduced games and the game he/she chose from the tablet was turned on. Children were asked to wear headphones for sound isolation and the sound was adjusted at the appropriate decibel setting. Half an hour before the treatment, children were allowed to play the video game until the treatment without any different warning. Physiologic Parameter Assessment Form, Child Anxiety and Fear Scale, Child Pain Scale were filled by the researcher 1 minute before and 1 minute after the procedure. Finally, Parental Satisfaction Scale was completed at the end of the intervention.

**Name:** Video game with headset

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** A descriptive characteristics information form for parents and children was prepared by the researchers in line with the literature and the data of both the experimental and control groups were collected before the intervention.

**Measure:** Descriptive Characteristics Information Form

**Time Frame:** First measurement: 30 minute before treatment

**Description:** The descriptive characteristics form was based on a literature review by the investigator. Heart rate (min), oxygen saturation (SpO2%), blood pressure (mmHg) and respiratory rate (min) were measured 1 minute before treatment administration.

**Measure:** Physiological Parameter Monitoring Form

**Time Frame:** First measurement: 1 minute before treatment

**Description:** Children's State Anxiety and Children's Fear Scale was developed by McMurtry et al. in 2011. The scale was designed to measure the fear levels of children aged 4-10 years. The scale was translated into Turkish by Gerçeker et al. in 2018 and the validity-reliability coefficient was found to be 0.89. The scale score is formed by scoring five drawn facial expressions (0=no fear to 4=severe fear) shown visually to the child. Anxiety and fear scores of the child were scored one minute before the treatment.

**Measure:** Children's State Anxiety and Children's Fear Scale

**Time Frame:** First measurement: 1 minute before treatment

**Description:** Visual Analog Scale (VAS) was developed by Wong and Baker in 1988. Patients' pain levels are evaluated by scoring with facial expressions. It is used in children who have the ability to communicate and are conscious. The scale has 6 faces that are scored between 0 and 5. In scoring, the child chooses the face that best expresses him/her and "0" indicates no pain, "1" indicates a little pain, "2" indicates a little more pain, "3" indicates more pain, "4" indicates quite a lot of pain and "5" indicates the most severe pain level. One minute before the treatment, the child's pain is scored by VAS.

**Measure:** Visual Analog Scale

**Time Frame:** First measurement: 1 minute before treatment

**Description:** The PedsQL Health Care Satisfaction Scale was developed by J.W. Varni in 1999. Turkish adaptation of the scale was conducted by Ulus and Kublay in 2012. The scale consists of 25 items with 6 subheadings: emotional support, information, general satisfaction, communication, family involvement and technical skills. The scale is on a five-point scale and each item is rated on a scale of 0 to 4 and is evaluated as "Never satisfied (0)", "Sometimes satisfied (1)", "Most of the time satisfied (2)", "Almost always satisfied (3)" and "Always satisfied (4)". A high score indicates an increase in parental satisfaction.

**Measure:** PedsQL Health Care Satisfaction Scale

**Time Frame:** First measurement: After treatment

#### Secondary Outcomes

**Description:** Heart rate (min), oxygen saturation (SpO2%), blood pressure (mmHg) and respiratory rate (min) were measured one minute after treatment administration.

**Measure:** Physiological Parameter Monitoring Form

**Time Frame:** Second measurement: 1 minute after treatment

**Description:** 1 minute after the treatment, the child's anxiety and fear score was scored again.

**Measure:** Children's State Anxiety and Children's Fear Scale

**Time Frame:** Second measurement: 1 minute after treatment

**Description:** One minute after the treatment, the child's pain score was scored again

**Measure:** Visual Analog Scale

**Time Frame:** Second measurement: 1 minute after treatment

### Eligibility Module

**Eligibility Criteria:** For the Child;

Inclusion Criteria:

* Being in the 3-6 age group,
* At least one day of inpatient treatment in the pediatric clinics of Selçuk Medical Faculty Hospital
* At least one invasive intervention in the treatment plan
* To be able to understand and speak Turkish
* Staying in a room with at least two beds

Exclusion Criteria:

* Having a neurological disorder
* Not having a parent as a companion
* Receiving oral treatment only
* Hearing and vision problems
* Single bed capacity room or isolated room

For the Parent

Inclusion Criteria:

* Staying with their child as a constant companion
* To be able to understand and speak Turkish
* Accepting to participate in the study

The exclusion criteria:

* Not staying with your child all the time

**Maximum Age:** 6 Years

**Minimum Age:** 3 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Konya

**Country:** Turkey

**Facility:** Selcuk University

#### Overall Officials

**Official 1:**

**Affiliation:** Selcuk University

**Name:** Sibel Kucukoglu, Prof

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Description:** It will be shared after the article is published.

**IPD Sharing:** NO

### References Module

#### References

**Citation:** Bergomi P, Scudeller L, Pintaldi S, Dal Molin A. Efficacy of Non-pharmacological Methods of Pain Management in Children Undergoing Venipuncture in a Pediatric Outpatient Clinic: A Randomized Controlled Trial of Audiovisual Distraction and External Cold and Vibration. J Pediatr Nurs. 2018 Sep-Oct;42:e66-e72. doi: 10.1016/j.pedn.2018.04.011. Epub 2018 May 1.

**PMID:** 29728296

**Citation:** Silva SGTD, Santos MA, Floriano CMF, Damiao EBC, Campos FV, Rossato LM. Influence of Therapeutic Play on the anxiety of hospitalized school-age children: Clinical trial. Rev Bras Enferm. 2017 Nov-Dec;70(6):1244-1249. doi: 10.1590/0034-7167-2016-0353. English, Portuguese.

**PMID:** 29160486

**Citation:** Roberts JG, Prys-Roberts C, Foex P, Clarke TN, Bennett M. Proceedings: A comparison of the effects of practolol and propranolol on the response to haemorrhage in anaesthetized dogs after myocardial infarction. Br J Anaesth. 1973 Dec;45(12):1230. doi: 10.1093/bja/45.12.1230. No abstract available.

**PMID:** 4787017

**Citation:** Kose S, Arikan D. The Effects of Cartoon Assisted Endoscopy Preparation Package on Children's Fear and Anxiety Levels and Parental Satisfaction in Turkey. J Pediatr Nurs. 2020 Jul-Aug;53:e72-e79. doi: 10.1016/j.pedn.2020.02.010. Epub 2020 Mar 13.

**PMID:** 32173165

**Citation:** Inan G, Inal S. The Impact of 3 Different Distraction Techniques on the Pain and Anxiety Levels of Children During Venipuncture: A Clinical Trial. Clin J Pain. 2019 Feb;35(2):140-147. doi: 10.1097/AJP.0000000000000666.

**PMID:** 30362982

**Citation:** Masmoudi A, el-Fetouaki J, Weltin D, Belhadj O, Mandel P. Association of mitochondrial ADP-ribosyl transferase activity with the DNA-protein complex. Biochem Mol Biol Int. 1993 Jan;29(1):77-83.

**PMID:** 8387848

**Citation:** Burns-Nader S, Joe L, Pinion K. Computer tablet distraction reduces pain and anxiety in pediatric burn patients undergoing hydrotherapy: A randomized trial. Burns. 2017 Sep;43(6):1203-1211. doi: 10.1016/j.burns.2017.02.015. Epub 2017 Mar 18.

**PMID:** 28318748

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M4324

- Name: Anxiety Disorders

- Relevance: HIGH

- As Found: Anxiety

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001008

- Term: Anxiety Disorders

### Misc Info Module

- Version Holder: 2024-05-31
