## Protocol Section
### Identification Module
**NCT ID:** NCT06416384

**Brief Title:** Post-Dialysis Fatigue and Recovery Time in Hemodialysis Patients

**Official Title:** The Effect of Hand Massage on Post-Dialysis Fatigue and Recovery Time in Hemodialysis Patients

#### Organization Study ID Info
**ID:** AU-SBE-SA-02
#### Organization
**Class:** OTHER
**Full Name:** Amasya University
### Status Module
#### Completion Date
**Date:** 2024-05-07

**Type:** ESTIMATED

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

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-14

**Overall Status:** ACTIVE_NOT_RECRUITING

#### Primary Completion Date
**Date:** 2024-02-07

**Type:** ACTUAL

#### Start Date
**Date:** 2024-01-09

**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:** 2024-05-14
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Amasya University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** This study aims to examine the effect of hand massage on patients receiving HD treatment on the severity of post-dialysis fatigue and post-dialysis recovery time.

**Detailed Description:** After obtaining the necessary permissions for the research, informing the patients about the purpose, importance and method of the study by the researcher, and having the volunteer patients read and sign a consent form, the patients were randomly divided into two groups. Randomization of the groups was done in a computer environment.

### Conditions Module

**Conditions:**

- Hemodialysis

- Fatigue

- Massage

**Keywords:**

- hemodialysis patient

- fatique

- hand massage

- nursing

- recovery time

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** It is a randomized controlled, single-blind, experimental study.

##### Masking Info

**Masking:** SINGLE

**Masking Description:** Single-blind (outcomes assessor)

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 48

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** The researcher applied a hand massage to the hand area of the patients in the experimental group on the side without fistula for five minutes, three times a week for four weeks.

**Intervention Names:**

- Other: Control Group

**Label:** Hand Massage Group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Patients in the control group received routine nursing care in the clinic for four weeks.

**Intervention Names:**

- Other: Hand Massage Group

**Label:** Control Group

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Control Group

**Description:** The patients in the hand massage application group were asked by the researcher; Hand massage with olive oil was applied 12 times in total, three times a week for four weeks. No application was made to the side with fistula.

**Name:** Hand Massage Group

**Other Names:**

- Experimental

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Hand Massage Group

**Description:** Patients in the control group received routine nursing care in the clinic for four weeks.

**Name:** Control Group

**Other Names:**

- Control

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Fatigue severity was evaluated before starting the application (pre-test)

Post-Dialysis Fatigue Scale: Kodama et al. The "Post-Dialysis Fatigue Scale" developed by (2020) is a five-item likert type scale consisting of 13 items. The scale is used to evaluate the severity of fatigue by examining the factors associated with fatigue observed after the end of treatment in dialysis patients. According to Özen et al. (2021) the total number of items in the scale after Turkish validity and reliability made by is 11.

**Measure:** fatigue severity

**Time Frame:** one week= first session

**Description:** Recovery time after dialysis was evaluated before starting the application (pre-test)

**Measure:** recovery time

**Time Frame:** One week= first session

#### Secondary Outcomes

**Description:** The effect of hand massage on fatigue severity was measured

Post-Dialysis Fatigue Scale: Kodama et al. The "Post-Dialysis Fatigue Scale" developed by (2020) is a five-item likert type scale consisting of 13 items. The scale is used to evaluate the severity of fatigue by examining the factors associated with fatigue observed after the end of treatment in dialysis patients. According to Özen et al. (2021) the total number of items in the scale after Turkish validity and reliability made by is 11.

**Measure:** fatique severity

**Time Frame:** After 4 weeks

**Description:** The effect of hand massage on recovery time after dialysis was measured

**Measure:** recovery time after dialysis

**Time Frame:** After 4 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Those who are 18 years or older,
* Receiving hemodialysis treatment for at least 3 months,
* Receiving hemodialysis treatment three times a week,
* Does not have any open wounds in the area to be applied,
* No active fistula in the arm to be treated,
* Does not have a hearing impairment,
* Sufficient to understand the questions,
* Open to communication and cooperation,
* Volunteer and willing for research

Exclusion Criteria:

* Having an active oncological problem or receiving oncological treatment,
* Those with health problems that require contact isolation,
* The number of dialysis sessions changed during the study,
* Those who lost their lives while working,
* Those who had a kidney transplant during the study,
* Those who want to leave voluntarily at any stage of the study

**Maximum Age:** 100 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Amasya

**Country:** Turkey

**Facility:** Amasya University İnstitute of Health Sciences

**State:** Merkez

**Zip:** 05100

#### Overall Officials

**Official 1:**

**Affiliation:** Amasya University

**Name:** Eylem Topbaş, Phd

**Role:** STUDY_DIRECTOR

**Official 2:**

**Affiliation:** Amasya University health sciences institute

**Name:** Seyit Ahmet KORKMAZ

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Description:** It can only be shared after publication upon special request from the authors.

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M8364

- Name: Fatigue

- Relevance: HIGH

- As Found: Fatigue

### Condition Browse Module - Meshes

- ID: D000005221

- Term: Fatigue

### Intervention Browse Module - Browse Branches

- Abbrev: HB

- Name: Herbal and Botanical

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: T242

- Name: Olive

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
