The Effect of Reiki Therapy in Pediatric Oncology Patients

Study Overview
=================
Brief Summary
-----------------
The study was conducted based on randomized controlled experimental design with double-blind, pre-test-post-test to determine the effect of Reiki applied to pediatric oncology patients aged 5-7 years on pain, vital signs, oxygen saturation (SpO2) and quality of life. While the population of the study consisted of oncology patients aged 5-7 years who were hospitalized in the pediatric oncology services between December 2020 and November 2021, the sample consisted of 66 children diagnosed with leukemia who met the sample selection criteria. The research consists of 3 groups. These groups are Reiki group (n=22), Placebo group (n=22), control group (n=22). The data are collected using Introductory Information Form, Wong-Baker FACES Pain Scale (W-BPS), Vital Signs Follow-up Form, The Pediatric Quality of Life Inventory (PedsQL) 3.0 Cancer Module Child and Parent Form. Reiki was applied to the Reiki group for 20-30 minutes for three consecutive days and Placebo was applied to the sham Reiki group by an independent nurse during the same application period. The children in the control group were like the routine of the ward.

Detailed Description
-----------------
The universe of the study consisted of pediatric oncology patients who met the selection criteria in the pediatric oncology services. The study was planned as a randomized controlled experimental design with double-blind, pre-test post-test to determine the effect of Reiki applied to pediatric oncology patients aged 5-7 years on pain, vital signs, oxygen saturation (SpO2) and quality of life. In order for the groups to be distributed homogeneously, the order produced by a computer program (http://www.randomization.com , Balanced permutation) was used. Patients who meet the inclusion criteria and agree to participate in the study assigned to the experimental and control groups according the randomization list. The control variable of the study is demographic characteristics of the children. The dependent variables of the study are pain, vital signs, oxygen saturation parameters and quality of life score.

Official Title
-----------------
The Effect of Reiki Therapy on Pain, Vital Signs and Quality of Life in Pediatric Oncology Patients

Conditions
-----------------
Reiki

Intervention / Treatment
-----------------
* Other: Reiki
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Being treated in the pediatric oncology service at the time of the study Being between 5-7 years old Body temperature being within normal limits To have received at least 1 course of chemotherapy Absence of visual, auditory problems or mental retardation at a level that can fill the scales, Exclusion Criteria: To have taken analgesic medication in the last 6 hours, Have received any energy and body-mind therapy (yoga, reiki, massage, meditation, healing touch) in the last six months

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 7 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study are conducted based on randomized controlled experimental design with double-blind, pre-test-post-test to determine. The research consists of 3 groups. These groups are Reiki group, Placebo group, control group.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reiki Group<br>Reiki is applied to the Reiki group for 20-30 minutes for three consecutive days. | Other: Reiki<br>* Reiki is applied to the Reiki group for 20-30 minutes for three consecutive days.<br>|
| Placebo Comparator: Placebo Group<br>Placebo group is applied to the sham Reiki group for 20-30 minutes for three consecutive days Placebo Reiki group is applied to the sham Reiki by an independent nurse during the same application period. | Other: Placebo<br>* Placebo group is applied to the sham Reiki group for 20-30 minutes for three consecutive days by an independent nurse during the same application period.<br>* Other names: Sham Reiki;|
| No Intervention: Control Group<br>No intervention is made in the control group. Standard care was used | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the pain score values of the groups | The Wong-Baker Faces Pain Scale revised (W-BFS) was used to determine the level of pain during the procedure. The W-BFS is a scale that is most commonly used in identifying pain in children of the ages 3 to 18. It is reported that the scale is reliable when used with children older than the age of 3 who can verbally express the degree of pain they feel. The scale is made up of faces and numbers. Pain is assessed on a scale of 0 to 10. Pain is described by selecting the facial expression depicting the degree of perceived pain. | Children's pain levels will be evaluated on the 1st day. | 
| Comparison of the pain score values of the groups | The Wong-Baker Faces Pain Scale revised (W-BFS) was used to determine the level of pain during the procedure. The W-BFS is a scale that is most commonly used in identifying pain in children of the ages 3 to 18. It is reported that the scale is reliable when used with children older than the age of 3 who can verbally express the degree of pain they feel. The scale is made up of faces and numbers. Pain is assessed on a scale of 0 to 10. Pain is described by selecting the facial expression depicting the degree of perceived pain. | Children's pain levels will be evaluated on the 2nd day. | 
| Comparison of the pain score values of the groups | The Wong-Baker Faces Pain Scale revised (W-BFS) was used to determine the level of pain during the procedure. The W-BFS is a scale that is most commonly used in identifying pain in children of the ages 3 to 18. It is reported that the scale is reliable when used with children older than the age of 3 who can verbally express the degree of pain they feel. The scale is made up of faces and numbers. Pain is assessed on a scale of 0 to 10. Pain is described by selecting the facial expression depicting the degree of perceived pain. | Children's pain levels will be evaluated on the 3rd day. | 
| Comparison of the heart rate values of the groups | Finger type portable Creative PC 60 pulse oximeter device was used to measure the heart rate values of the children. | Children's heart rate values will be evaluated on the 1st day. | 
| Comparison of the heart rate values of the groups | Finger type portable Creative PC 60 pulse oximeter device was used to measure the heart rate values of the children. | Children's heart rate values will be evaluated on the 2nd day. | 
| Comparison of the heart rate values of the groups | Finger type portable Creative PC 60 pulse oximeter device was used to measure the heart rate values of the children. | Children's heart rate values will be evaluated on the 3rd day. | 
| Comparison of the respiratory rate values of the groups | The respiratory rate values of the children will be measured by counting for 1 minute. | Children's respiratory rate values will be evaluated on the 1st day. | 
| Comparison of the respiratory rate values of the groups | The respiratory rate values of the children will be measured by counting for 1 minute. | Children's respiratory rate values will be evaluated on the 2nd day. | 
| Comparison of the respiratory rate values of the groups | The respiratory rate values of the children will be measured by counting for 1 minute. | Children's respiratory rate values will be evaluated on the 3rd day. | 
| Comparison of the body temperature values of the groups | Cem brand infrared thermometer device was used to measure body temperature of the children. | Children's body temperature values will be evaluated on the 1st day. | 
| Comparison of the body temperature values of the groups | Cem brand infrared thermometer device was used to measure body temperature of the children. | Children's body temperature values will be evaluated on the 2nd day. | 
| Comparison of the body temperature values of the groups | Cem brand infrared thermometer device was used to measure body temperature of the children. | Children's body temperature values will be evaluated on the 3rd day. | 
| Comparison of the oxygen saturation values of the groups | Finger type portable Creative PC 60 pulse oximeter device was used to measure the oxygen saturation values of the children. | Children's oxygen saturation values will be evaluated on the 1st day. | 
| Comparison of the oxygen saturation values of the groups | Finger type portable Creative PC 60 pulse oximeter device was used to measure the oxygen saturation values of the children. | Children's oxygen saturation values will be evaluated on the 2nd day. | 
| Comparison of the oxygen saturation values of the groups | Finger type portable Creative PC 60 pulse oximeter device was used to measure the oxygen saturation values of the children. | Children's oxygen saturation values will be evaluated on the 3rd day. | 
| Comparison of Groups' Quality of Life Scale (PedsQL 3.0 Cancer Module) Scores | The Child and Parent Reports of the PedsQL 3.0 Cancer Module for Young Children (ages 5-7), are composed of 26 items comprising 8 dimensions. Scores are transformed on a scale from 0 to 100. Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. Higher scores indicate lower problems. | Measurements will be made before on the 1st and after 3rd days the intervention. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Reiki Touch Therapy, Pediatric Oncology, Pain, Quality of Life, Vital Signs