Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06296680 |
| Other study ID # |
EGE_UNI_SEVCAN_OZ_KAHVECI_0001 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 2, 2022 |
| Est. completion date |
June 30, 2023 |
Study information
| Verified date |
February 2024 |
| Source |
Ege University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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
member/caregiver 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 researcher's 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 patient's 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 practitioner's 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.
