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Completed

NCT Number: NCT05698953

The Effect of Reiki Therapy 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.

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Key information

Conditions

Reiki Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

5 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Yalova

Yalova, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

reiki

Other

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

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.

Other names: Sham Reiki

Primary outcomes

  1. Comparison of the pain score values of the groups

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Yalova

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jan 26, 2023
Registry last updated
Jun 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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