The Effect of Reiki Therapy in Pediatric Oncology Patients

June 17, 2023 updated by: Duygu Demir, University of Yalova

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Yalova, Turkey
        • University of Yalova

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 7 years (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Reiki Group
Reiki is applied to the Reiki group for 20-30 minutes for three consecutive days.
Other: Reiki
Reiki is applied to the Reiki group for 20-30 minutes for three consecutive days.
Placebo Comparator: Placebo Group
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
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.
Other Names:
  • Sham Reiki
No Intervention: Control Group
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
Time Frame: Children's pain levels will be evaluated on the 1st day.

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
Time Frame: Children's pain levels will be evaluated on the 2nd day.

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
Time Frame: Children's pain levels will be evaluated on the 3rd day.

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
Time Frame: Children's heart rate values will be evaluated on the 1st day.
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
Time Frame: Children's heart rate values will be evaluated on the 2nd day.
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
Time Frame: Children's heart rate values will be evaluated on the 3rd day.
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
Time Frame: Children's respiratory rate values will be evaluated on the 1st day.
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
Time Frame: Children's respiratory rate values will be evaluated on the 2nd day.
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
Time Frame: Children's respiratory rate values will be evaluated on the 3rd day.
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
Time Frame: Children's body temperature values will be evaluated on the 1st day.
"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
Time Frame: Children's body temperature values will be evaluated on the 2nd day.
"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
Time Frame: Children's body temperature values will be evaluated on the 3rd day.
"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
Time Frame: Children's oxygen saturation values will be evaluated on the 1st day.
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
Time Frame: Children's oxygen saturation values will be evaluated on the 2nd day.
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
Time Frame: Children's oxygen saturation values will be evaluated on the 3rd day.
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
Time Frame: Measurements will be made before on the 1st and after 3rd days the intervention.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Yalova

Investigators

  • Study Chair: Duygu Demir, PhD, Istanbul University - Cerrahpasa (IUC)
  • Study Director: Birsen Mutlu, Assoc. Prof., Istanbul University - Cerrahpasa (IUC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2020

Primary Completion (Actual)

February 1, 2023

Study Completion (Actual)

March 1, 2023

Study Registration Dates

First Submitted

January 2, 2023

First Submitted That Met QC Criteria

January 16, 2023

First Posted (Actual)

January 26, 2023

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 17, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • duygudemir

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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