The Effect of Reiki Therapy in Pediatric Oncology Patients

NCT ID: NCT05698953

Last Updated: 2023-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-01

Study Completion Date

2023-03-01

Brief Summary

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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

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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.

Conditions

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Reiki

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants
The research consists of 3 groups. These groups are Reiki group, Placebo group, control group.

Study Groups

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Reiki Group

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

Group Type EXPERIMENTAL

Reiki

Intervention Type OTHER

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

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type 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.

Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Reiki

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

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

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Sham Reiki

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Yalova

OTHER

Sponsor Role lead

Responsible Party

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Duygu Demir

Research Assistant - PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Duygu Demir, PhD

Role: STUDY_CHAIR

Istanbul University - Cerrahpasa

Birsen Mutlu, Assoc. Prof.

Role: STUDY_DIRECTOR

Istanbul University - Cerrahpasa

Locations

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University of Yalova

Yalova, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 12652885 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 21140870 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17627194 (View on PubMed)

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.

Reference Type RESULT
PMID: 34262006 (View on PubMed)

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.

Reference Type RESULT
PMID: 33252426 (View on PubMed)

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.

Reference Type RESULT
PMID: 35722865 (View on PubMed)

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.

Reference Type RESULT
PMID: 27058159 (View on PubMed)

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.

Reference Type RESULT
PMID: 29315084 (View on PubMed)

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.

Reference Type RESULT
PMID: 31046557 (View on PubMed)

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.

Reference Type RESULT
PMID: 34647912 (View on PubMed)

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.

Reference Type RESULT
PMID: 17099413 (View on PubMed)

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.

Reference Type RESULT
PMID: 12889549 (View on PubMed)

Related Links

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http://www.nccih.nih.gov/health/reiki

The National Center of Complementary and Alternative Medicine (NCCAM)

Other Identifiers

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duygudemir

Identifier Type: -

Identifier Source: org_study_id

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