The Effect of Reiki Therapy in Pediatric Oncology Patients

Sponsor
University of Yalova (Other)
Overall Status
Recruiting
CT.gov ID
NCT05698953
Collaborator
(none)
66
1
3
26.8
2.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Reiki
  • Other: Placebo
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
66 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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 (Participant)
Masking Description:
The research consists of 3 groups. These groups are Reiki group, Placebo group, control group.
Primary Purpose:
Supportive Care
Official Title:
The Effect of Reiki Therapy on Pain, Vital Signs and Quality of Life in Pediatric Oncology Patients
Actual Study Start Date :
Dec 1, 2020
Anticipated Primary Completion Date :
Feb 1, 2023
Anticipated Study Completion Date :
Feb 26, 2023

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Comparison of the pain score values of the groups [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.

    2. Comparison of the pain score values of the groups [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.

    3. Comparison of the pain score values of the groups [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.

    4. Comparison of the heart rate values of the groups [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.

    5. Comparison of the heart rate values of the groups [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.

    6. Comparison of the heart rate values of the groups [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.

    7. Comparison of the respiratory rate values of the groups [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.

    8. Comparison of the respiratory rate values of the groups [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.

    9. Comparison of the respiratory rate values of the groups [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.

    10. Comparison of the body temperature values of the groups [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.

    11. Comparison of the body temperature values of the groups [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.

    12. Comparison of the body temperature values of the groups [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.

    13. Comparison of the oxygen saturation values of the groups [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.

    14. Comparison of the oxygen saturation values of the groups [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.

    15. Comparison of the oxygen saturation values of the groups [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.

    16. Comparison of Groups' Quality of Life Scale (PedsQL 3.0 Cancer Module) Scores [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    5 Years to 7 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Yalova Yalova Turkey

    Sponsors and Collaborators

    • University of Yalova

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Duygu Demir, Research Assistant - PhD, University of Yalova
    ClinicalTrials.gov Identifier:
    NCT05698953
    Other Study ID Numbers:
    • duygudemir
    First Posted:
    Jan 26, 2023
    Last Update Posted:
    Jan 26, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Duygu Demir, Research Assistant - PhD, University of Yalova
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 26, 2023