Clinical trial NCT05698953: The Effect of Reiki Therapy in Pediatric Oncology Patients
Official title: The Effect of Reiki Therapy on Pain, Vital Signs and Quality of Life in Pediatric Oncology Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Reiki
Keywords: Reiki Touch Therapy
Pediatric Oncology
Pain
Quality of Life
Vital Signs
Lead sponsor: University of Yalova
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 66
Sex: ALL
Minimum age (years): 5
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of the pain score values of the groups
timeFrame: Children's pain levels will be evaluated on the 1st day.
measure: Comparison of the pain score values of the groups
timeFrame: Children's pain levels will be evaluated on the 2nd day.
measure: Comparison of the pain score values of the groups
timeFrame: Children's pain levels will be evaluated on the 3rd day.
measure: Comparison of the heart rate values of the groups
timeFrame: Children's heart rate values will be evaluated on the 1st day.
measure: Comparison of the heart rate values of the groups
timeFrame: Children's heart rate values will be evaluated on the 2nd day.
measure: Comparison of the heart rate values of the groups
timeFrame: Children's heart rate values will be evaluated on the 3rd day.
measure: Comparison of the respiratory rate values of the groups
timeFrame: Children's respiratory rate values will be evaluated on the 1st day.
measure: Comparison of the respiratory rate values of the groups
timeFrame: Children's respiratory rate values will be evaluated on the 2nd day.
measure: Comparison of the respiratory rate values of the groups
timeFrame: Children's respiratory rate values will be evaluated on the 3rd day.
measure: Comparison of the body temperature values of the groups
timeFrame: Children's body temperature values will be evaluated on the 1st day.
measure: Comparison of the body temperature values of the groups
timeFrame: Children's body temperature values will be evaluated on the 2nd day.
measure: Comparison of the body temperature values of the groups
timeFrame: Children's body temperature values will be evaluated on the 3rd day.
measure: Comparison of the oxygen saturation values of the groups
timeFrame: Children's oxygen saturation values will be evaluated on the 1st day.
measure: Comparison of the oxygen saturation values of the groups
timeFrame: Children's oxygen saturation values will be evaluated on the 2nd day.
measure: Comparison of the oxygen saturation values of the groups
timeFrame: Children's oxygen saturation values will be evaluated on the 3rd day.
measure: Comparison of Groups' Quality of Life Scale (PedsQL 3.0 Cancer Module) Scores
timeFrame: Measurements will be made before on the 1st and after 3rd days the intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: Yalova
country: Turkey
facility: University of Yalova
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Duygu Demir, PhD
role: STUDY_CHAIR
affiliation: Istanbul University - Cerrahpasa
name: Birsen Mutlu, Assoc. Prof.
role: STUDY_DIRECTOR
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