The Effect of Reiki Therapy in Pediatric Oncology Patients

NCT05698953 | Completed DMC

• 1 other identifier: duygudemir
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Reiki

Keywords

Reiki Touch Therapy; Pediatric Oncology; Pain; Quality of Life; Vital Signs

Outcome Measures

Primary Outcomes (16)

• 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.

Study Arms (3)

Reiki Group

EXPERIMENTAL

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

Other: Reiki

Placebo Group

PLACEBO COMPARATOR

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

Control Group

NO INTERVENTION

No intervention is made in the control group. Standard care was used

Interventions

Reiki OTHER

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

Reiki Group

Placebo OTHER

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.

Also known as: Sham Reiki

Placebo Group

Eligibility Criteria

• Age: 5 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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,

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Yalova: lead

Study Sites (1)

University of Yalova

Yalova, Turkey (Türkiye)

Location

Related Publications (12)

• 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.

  PMID: 12652885 BACKGROUND

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

  PMID: 21140870 BACKGROUND

• 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.

  PMID: 17627194 BACKGROUND

• 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.

  PMID: 34262006 RESULT

• 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.

  PMID: 33252426 RESULT

• 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.

  PMID: 35722865 RESULT

• 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. Epub 2016 Mar 30.

  PMID: 27058159 RESULT

• 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.

  PMID: 29315084 RESULT

• 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. 2019 Sep/Oct;36(5):361-368. doi: 10.1177/1043454219845879. Epub 2019 May 3.

  PMID: 31046557 RESULT

• 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.

  PMID: 34647912 RESULT

• 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.

  PMID: 17099413 RESULT

• 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.

  PMID: 12889549 RESULT

Related Links

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

MeSH Terms

Conditions

Pain

Interventions

Therapeutic Touch

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies

Study Officials

• Duygu Demir, PhD

  Istanbul University - Cerrahpasa

  STUDY CHAIR

• Birsen Mutlu, Assoc. Prof.

  Istanbul University - Cerrahpasa

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The research consists of 3 groups. These groups are Reiki group, Placebo group, control group.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant - PhD

Model Details: 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.

Study Record Dates

• First Submitted: January 2, 2023
• First Posted: January 26, 2023
• Study Start: December 1, 2020
• Primary Completion: February 1, 2023
• Study Completion: March 1, 2023
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)