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ReikiNCT05698953

The Effect of Reiki Therapy in Pediatric Oncology Patients

A study testing Reiki in people with Reiki, run by University of Yalova at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 5 to 7 years
Conditions the study is for
Reiki
What is being tested?
Reiki
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
66 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Dec 2020to 1 Mar 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 7 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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,

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • University of Yalova

    Yalova

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Conditions
Reiki
Being tested
Reiki, Placebo
Keywords
Reiki Touch Therapy, Pediatric Oncology, Pain, Quality of Life, Vital Signs
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ReikiOther

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

  • PlaceboOther

    Also called Sham Reiki

    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.

Study groups in NCT05698953
Study groupRoleWhat they receive
Reiki GroupExperimentalReiki is applied to the Reiki group for 20-30 minutes for three consecutive days.
Receives: Other: Reiki
Placebo GroupPlacebo comparatorPlacebo 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.
Receives: Other: Placebo
Control GroupNo interventionNo intervention is made in the control group. Standard care was used

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Children's pain levels will be evaluated on the 1st day.

  2. 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.

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

  3. 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.

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

  4. 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.

    Measured: Children's heart rate values will be evaluated on the 1st day.

  5. 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.

    Measured: Children's heart rate values will be evaluated on the 2nd day.

  6. 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.

    Measured: Children's heart rate values will be evaluated on the 3rd day.

  7. Comparison of the respiratory rate values of the groups

    The respiratory rate values of the children will be measured by counting for 1 minute.

    Measured: Children's respiratory rate values will be evaluated on the 1st day.

  8. Comparison of the respiratory rate values of the groups

    The respiratory rate values of the children will be measured by counting for 1 minute.

    Measured: Children's respiratory rate values will be evaluated on the 2nd day.

  9. Comparison of the respiratory rate values of the groups

    The respiratory rate values of the children will be measured by counting for 1 minute.

    Measured: Children's respiratory rate values will be evaluated on the 3rd day.

  10. Comparison of the body temperature values of the groups

    "Cem brand" infrared thermometer device was used to measure body temperature of the children.

    Measured: Children's body temperature values will be evaluated on the 1st day.

  11. Comparison of the body temperature values of the groups

    "Cem brand" infrared thermometer device was used to measure body temperature of the children.

    Measured: Children's body temperature values will be evaluated on the 2nd day.

  12. Comparison of the body temperature values of the groups

    "Cem brand" infrared thermometer device was used to measure body temperature of the children.

    Measured: Children's body temperature values will be evaluated on the 3rd day.

  13. 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.

    Measured: Children's oxygen saturation values will be evaluated on the 1st day.

  14. 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.

    Measured: Children's oxygen saturation values will be evaluated on the 2nd day.

  15. 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.

    Measured: Children's oxygen saturation values will be evaluated on the 3rd day.

  16. 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.

    Measured: Measurements will be made before on the 1st and after 3rd days the intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2023
  2. Study start1 Dec 2020
  3. Primary completion1 Feb 2023
  4. Study completion1 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Single blind
Who is masked
Participant
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05698953
Sponsor's protocol ID
duygudemir
Status last verified
Jun 2023
First submitted
2 Jan 2023
Last updated
22 Jun 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 12652885
  • Natale GW. Reconnecting to nursing through Reiki. Creat Nurs. 2010;16(4):171-6. doi: 10.1891/1078-4535.16.4.171.

    PubMed 21140870
  • 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.

    PubMed 17627194
  • 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.

    PubMed 34262006
  • 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.

    PubMed 33252426
  • 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.

    PubMed 35722865
  • 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.

    PubMed 27058159
  • 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.

    PubMed 29315084
  • 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.

    PubMed 31046557
  • 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.

    PubMed 34647912
  • 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.

    PubMed 17099413
  • 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.

    PubMed 12889549

Questions about this trial

What is this clinical trial studying?

A study testing Reiki in people with Reiki, run by University of Yalova at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison of the pain score values of the groups (time frame: Children's pain levels will be evaluated on the 1st day.). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05698953, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.

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