Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06296680
Status:
COMPLETED
Last Update Posted:
2024-03-06
First Post:
2024-02-29
Brief Title:
Reiki for Cancer Pain Anxiety and Stress
Sponsor:
Ege University
Organization:
Ege University
Study Overview
Official Title:
The Effect of Reiki Applied to Cancer Patients on Pain Anxiety and Stress Levels A Randomized Controlled Study
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to investigate the effects of Reiki Sham Reiki and Progressive Relaxation Exercise on the levels of pain anxiety and stress in cancer patients
The main questions it aims to answer are
Question 1 The effect of Reiki applied to cancer patients on the level of pain within the time series is higher in favor of the intervention group
Question 2 The effect of Reiki applied to cancer patients on the level of anxiety within the time series is higher in favor of the intervention group
Question 3 The effect of Reiki applied to cancer patients on cortisol levels within the time series is higher in favor of the intervention group
Question 4 The effect of Reiki applied to cancer patients on the level of stress within the time series is higher in favor of the intervention group
Participants have answered the questions in the Individual Identification Form Visual Comparison Scale State Anxiety Scale and Perceived Stress Scale and serum cortisol levels were evaluated in the pretest
Afterwards the patients in the intervention group received Reiki for four consecutive days the patients in the placebo group received Sham Reiki and the patients in the control group received Progressive Relaxation Exercise
The patients in the experimental group received Reiki to the seven chakra regions and additional areas with pain for a total duration of 25-30 minutes for four days with an average of three minutes
The patients in the placebo group received Sham Reiki to the seven chakra regions for a total duration of 25-30 minutes for four days with an average of three minutes
Progressive Relaxation Exercise PRE group patients received PRE for four days
On the 4th day pain and anxiety levels 0-10 Likert-type scale of the patients were evaluated after the last applications
On the 21st day the day of the next chemotherapy cycle pain and anxiety levels were evaluated state anxiety scale and perceived stress scale were administered and serum cortisol level was evaluated in the morning before the start of chemotherapy
At the 3rd month follow-up pain and anxiety levels 0-10 Likert-type scale state anxiety scale and perceived stress scale were evaluated
The main questions it aims to answer are
Question 1 The effect of Reiki applied to cancer patients on the level of pain within the time series is higher in favor of the intervention group
Question 2 The effect of Reiki applied to cancer patients on the level of anxiety within the time series is higher in favor of the intervention group
Question 3 The effect of Reiki applied to cancer patients on cortisol levels within the time series is higher in favor of the intervention group
Question 4 The effect of Reiki applied to cancer patients on the level of stress within the time series is higher in favor of the intervention group
Participants have answered the questions in the Individual Identification Form Visual Comparison Scale State Anxiety Scale and Perceived Stress Scale and serum cortisol levels were evaluated in the pretest
Afterwards the patients in the intervention group received Reiki for four consecutive days the patients in the placebo group received Sham Reiki and the patients in the control group received Progressive Relaxation Exercise
The patients in the experimental group received Reiki to the seven chakra regions and additional areas with pain for a total duration of 25-30 minutes for four days with an average of three minutes
The patients in the placebo group received Sham Reiki to the seven chakra regions for a total duration of 25-30 minutes for four days with an average of three minutes
Progressive Relaxation Exercise PRE group patients received PRE for four days
On the 4th day pain and anxiety levels 0-10 Likert-type scale of the patients were evaluated after the last applications
On the 21st day the day of the next chemotherapy cycle pain and anxiety levels were evaluated state anxiety scale and perceived stress scale were administered and serum cortisol level was evaluated in the morning before the start of chemotherapy
At the 3rd month follow-up pain and anxiety levels 0-10 Likert-type scale state anxiety scale and perceived stress scale were evaluated
Detailed Description:
Patients were assigned to intervention placebo and control groups according to a randomization list Laboratory fees for serum cortisol analyses were covered from a separate budget to ensure patients under the coverage of the Social Security Institution did not experience any deduction of fees For each patient consenting to participate in the study contact was made with the Ege University Faculty of Medicine Project and Special Services Coordination Center PROKOM for Research Patient Identification followed by contacting the Hospital Information Processing Department to open a Research Patient record Laboratory requisitions for patients were made by the attending physician Following serum cortisol analyses data from the Individual Identification Form Visual Analog Scale State Anxiety Inventory Perceived Stress Scale were collected from patients Patients consenting to participate in the study were then initiated on treatment plans by a researcher with Level One certification in Reiki and PGE Progressive Relaxation Exercise Sham Reiki was administered by Sham Reiki practitioners Patient rooms in the clinic were single occupancy and efforts were made to control noise during interventions Any accompanying family membercaregiver present in the room during the intervention was asked to leave for the duration of the application
Intervention Group Reiki Group
Pre-test Prior to initiating Reiki application blood samples were obtained from the patients to assess serum cortisol levels subsequently data from the Individual Identification Form Visual Analog Scale State Anxiety Inventory Perceived Stress Scale were collected by the researcher through face-to-face interviews Reiki was administered for four days at designated times Reiki was applied for a total duration of 25-30 minutes with approximately three minutes per chakra region and the area of pain while the patient was in a supine position and the researchers hands were positioned two to three centimeters above the chakra regions
Fourth-day follow-up Data from the Visual Analog Scale were collected and anxiety scores were evaluated
Twenty-first-day follow-up Patients serum cortisol levels were re-evaluated just before the start of their next chemotherapy session between days 21-28 before initiating their current medical treatment patients use cortisol alongside chemotherapy treatment and data from the Visual Analog Scale State Anxiety Inventory and Perceived Stress Scale were collected
Three-month follow-up Data from the Visual Analog Scale State Anxiety Inventory and Perceived Stress Scale were collected from the patients
Placebo Group Sham Reiki Group
Pre-test Prior to initiating Sham Reiki application blood samples were obtained from the patients to assess cortisol levels subsequently data from the Individual Identification Form Visual Analog Scale State Anxiety Inventory Perceived Stress Scale were collected by the researcher through face-to-face interviews Sham Reiki was administered for four days at designated times In this study Sham Reiki practitioners mimicked a Reiki session by moving their hands over the patients body in a specific sequence for a duration of 25-30 minutes Sham Reiki was applied for a total duration of 25-30 minutes with approximately three minutes per chakra region and the area of pain while the patient was in a supine position and the practitioners hands were positioned two to three centimeters above the chakra regions Sham Reiki practitioners consisted of nurses who did not believe in the transfer of biological field energy
Fourth-day follow-up Data from the Visual Analog Scale were collected and anxiety scores were evaluated
Twenty-first-day follow-up Patients serum cortisol levels were re-evaluated just before the start of their next chemotherapy session between days 21-28 before initiating their current medical treatment and data from the Visual Analog Scale State Anxiety Inventory and Perceived Stress Scale were collected
Three-month follow-up Data from the Visual Analog Scale State Anxiety Inventory and Perceived Stress Scale were collected from the patients
Control Group PGE Group
Pre-test Prior to initiating PGE application blood samples were obtained from the patients to assess cortisol levels subsequently data from the Individual Identification Form Visual Analog Scale State Anxiety Inventory Perceived Stress Scale were collected by the researcher through face-to-face interviews Patients received PGE for four days
Fourth-day follow-up Data from the Visual Analog Scale were collected again and anxiety scores were evaluated
Twenty-first-day follow-up Patients serum cortisol levels were re-evaluated just before the start of their next chemotherapy session between days 21-28 before initiating their current medical treatment and data from the Visual Analog Scale State Anxiety Inventory and Perceived Stress Scale were collected again
Three-month follow-up Data from the Visual Analog Scale State Anxiety Inventory and Perceived Stress Scale were collected from the patients
Intervention Group Reiki Group
Pre-test Prior to initiating Reiki application blood samples were obtained from the patients to assess serum cortisol levels subsequently data from the Individual Identification Form Visual Analog Scale State Anxiety Inventory Perceived Stress Scale were collected by the researcher through face-to-face interviews Reiki was administered for four days at designated times Reiki was applied for a total duration of 25-30 minutes with approximately three minutes per chakra region and the area of pain while the patient was in a supine position and the researchers hands were positioned two to three centimeters above the chakra regions
Fourth-day follow-up Data from the Visual Analog Scale were collected and anxiety scores were evaluated
Twenty-first-day follow-up Patients serum cortisol levels were re-evaluated just before the start of their next chemotherapy session between days 21-28 before initiating their current medical treatment patients use cortisol alongside chemotherapy treatment and data from the Visual Analog Scale State Anxiety Inventory and Perceived Stress Scale were collected
Three-month follow-up Data from the Visual Analog Scale State Anxiety Inventory and Perceived Stress Scale were collected from the patients
Placebo Group Sham Reiki Group
Pre-test Prior to initiating Sham Reiki application blood samples were obtained from the patients to assess cortisol levels subsequently data from the Individual Identification Form Visual Analog Scale State Anxiety Inventory Perceived Stress Scale were collected by the researcher through face-to-face interviews Sham Reiki was administered for four days at designated times In this study Sham Reiki practitioners mimicked a Reiki session by moving their hands over the patients body in a specific sequence for a duration of 25-30 minutes Sham Reiki was applied for a total duration of 25-30 minutes with approximately three minutes per chakra region and the area of pain while the patient was in a supine position and the practitioners hands were positioned two to three centimeters above the chakra regions Sham Reiki practitioners consisted of nurses who did not believe in the transfer of biological field energy
Fourth-day follow-up Data from the Visual Analog Scale were collected and anxiety scores were evaluated
Twenty-first-day follow-up Patients serum cortisol levels were re-evaluated just before the start of their next chemotherapy session between days 21-28 before initiating their current medical treatment and data from the Visual Analog Scale State Anxiety Inventory and Perceived Stress Scale were collected
Three-month follow-up Data from the Visual Analog Scale State Anxiety Inventory and Perceived Stress Scale were collected from the patients
Control Group PGE Group
Pre-test Prior to initiating PGE application blood samples were obtained from the patients to assess cortisol levels subsequently data from the Individual Identification Form Visual Analog Scale State Anxiety Inventory Perceived Stress Scale were collected by the researcher through face-to-face interviews Patients received PGE for four days
Fourth-day follow-up Data from the Visual Analog Scale were collected again and anxiety scores were evaluated
Twenty-first-day follow-up Patients serum cortisol levels were re-evaluated just before the start of their next chemotherapy session between days 21-28 before initiating their current medical treatment and data from the Visual Analog Scale State Anxiety Inventory and Perceived Stress Scale were collected again
Three-month follow-up Data from the Visual Analog Scale State Anxiety Inventory and Perceived Stress Scale were collected from the patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None