An interventional study of Reiki and Placebo in Reiki, sponsored by University of Yalova. Completed at 1 site in Turkey. Open to participants aged 5 Years to 7 Years. Per ClinicalTrials.gov, last updated 2023-06-22.
Sponsored by University of Yalova · Not applicable, Interventional, and Supportive care
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.
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.
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This study's enrollment of 66 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.
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Exclusion Criteria:
Reiki is applied to the Reiki group for 20-30 minutes for three consecutive days.
Other: Reiki
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
No intervention is made in the control group. Standard care was used
Reiki is applied to the Reiki group for 20-30 minutes for three consecutive days.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Measurements will be made before on the 1st and after 3rd days the intervention.
Plan to share: No
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University of Yalova