The Effect of Reiki Therapy in Pediatric Oncology Patients

Reiki Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05698953
• Other study ID #: duygudemir
• Status: Completed
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: March 1, 2023

Study information

• Verified date: June 2023
• Source: University of Yalova
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: March 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms
• Reiki

Intervention

Other:
• Reiki
Reiki is applied to the Reiki group for 20-30 minutes for three consecutive days.
• 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.

Locations

Country	Name	City	State
Turkey	University of Yalova	Yalova

Sponsors (1)

Lead Sponsor	Collaborator
University of Yalova

Country where clinical trial is conducted

Turkey, 

References & Publications (12)

Charkhandeh M, Talib MA, Hunt CJ. The clinical effectiveness of cognitive behavior therapy and an alternative medicine approach in reducing symptoms of depression in adolescents. Psychiatry Res. 2016 May 30;239:325-30. doi: 10.1016/j.psychres.2016.03.044. — View Citation

Kocoglu F, Zincir H. The Effect of Reiki on Pain, Fatigue, and Quality of Life in Adolescents With Dysmenorrhea. Holist Nurs Pract. 2021 Nov-Dec 01;35(6):306-314. doi: 10.1097/HNP.0000000000000477. — View Citation

Miles P, True G. Reiki--review of a biofield therapy history, theory, practice, and research. Altern Ther Health Med. 2003 Mar-Apr;9(2):62-72. — View Citation

Natale GW. Reconnecting to nursing through Reiki. Creat Nurs. 2010;16(4):171-6. doi: 10.1891/1078-4535.16.4.171. — View Citation

Radziewicz RM, Wright-Esber S, Zupancic J, Gargiulo D, Woodall P. Safety of Reiki Therapy for Newborns at Risk for Neonatal Abstinence Syndrome. Holist Nurs Pract. 2018 Mar/Apr;32(2):63-70. doi: 10.1097/HNP.0000000000000251. — View Citation

Thrane SE, Grossoehme DH, Tan A, Shaner V, Friebert S. Feasibility and Acceptability of a Reiki Intervention With Very Young Children Receiving Palliative Care. Nurs Res. 2021 Nov-Dec 01;70(6):469-474. doi: 10.1097/NNR.0000000000000540. — View Citation

Thrane SE, Maurer SH, Danford CA. Feasibility and Acceptability of Reiki Therapy for Children Receiving Palliative Care in the Home. J Hosp Palliat Nurs. 2021 Feb 1;23(1):52-58. doi: 10.1097/NJH.0000000000000714. — View Citation

Thrane SE, Williams E, Grossoehme DH, Friebert S. Reiki Therapy for Very Young Hospitalized Children Receiving Palliative Care. J Pediatr Hematol Oncol Nurs. 2022 Jan-Feb;39(1):15-29. doi: 10.1177/27527530211059435. — View Citation

Vitale A. An integrative review of Reiki touch therapy research. Holist Nurs Pract. 2007 Jul-Aug;21(4):167-79; quiz 180-1. doi: 10.1097/01.HNP.0000280927.83506.f6. — View Citation

Vitale AT, O'Connor PC. The effect of Reiki on pain and anxiety in women with abdominal hysterectomies: a quasi-experimental pilot study. Holist Nurs Pract. 2006 Nov-Dec;20(6):263-72; quiz 273-4. — View Citation

Whelan KM, Wishnia GS. Reiki therapy: the benefits to a nurse/Reiki practitioner. Holist Nurs Pract. 2003 Jul-Aug;17(4):209-17. doi: 10.1097/00004650-200307000-00008. — View Citation

Zucchetti G, Candela F, Bottigelli C, Campione G, Parrinello A, Piu P, Vassallo E, Fagioli F. The Power of Reiki: Feasibility and Efficacy of Reducing Pain in Children With Cancer Undergoing Hematopoietic Stem Cell Transplantation. J Pediatr Oncol Nurs. 2 — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.

External Links

•   The National Center of Complementary and Alternative Medicine (NCCAM)