Therapeutic TouchNCT06296680
Reiki for Cancer: Pain, Anxiety, and Stress
A study testing Reiki and Progressive Relaxation Exercise in people with Therapeutic Touch and Cancer, run by Ege University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Therapeutic Touch, Cancer
- What is being tested?
- Reiki and Progressive Relaxation Exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Sep 2022to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Conscious
- Aged 18 and over
- Without serious mental disorders (Bipolar Disorder, Schizophrenia, Schizoaffective Disorder, Major Depression, Personality Disorders)
- Without visual and hearing impairments
- Capable of verbal communication
- Never received Reiki before
- Patients scoring 36 or above on the Perceived Stress Scale were included in the study.
Who cannot join
- Patients using cortisol were not included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Reiki Applied to Cancer Patients on Pain, Anxiety, and Stress Levels: A Randomized Controlled Study
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.
Read the 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 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.
- Conditions
- Therapeutic Touch, Cancer
- Being tested
- Reiki, Sham Reiki, Progressive Relaxation Exercise
- Keywords
- Reiki, Cancer, Pain, Anxiety, Stress, Nursing
- Medical subject headings
- Neoplasms, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReikiOther
The patients in the intervention group received Reiki to the seven chakra regions and additional areas with pain for a total duration of 25-30 minutes for four consecutive days. On the 4th day, pain and anxiety levels of the patients were evaluated after the last applications. On the 21st day, 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, state anxiety scale and perceived stress scale were evaluated.
Sham ReikiOther
The patients in the placebo group received Sham Reiki to the seven chakra regions for a total duration of 25-30 minutes for four consecutive days. On the 4th day, pain and anxiety levels of the patients were evaluated after the last applications. On the 21st day, 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, state anxiety scale and perceived stress scale were evaluated.
Progressive Relaxation ExerciseOther
Also called the patients in the control group received Progressive Relaxation Exercise.
PRE group patients received PRE for four consecutive days. On the 4th day, pain and anxiety levels of the patients were evaluated after the last applications. On the 21st day, 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, state anxiety scale and perceived stress scale were evaluated.
| Study group | Role | What they receive |
|---|---|---|
| Reiki | Experimental | In the intervention group, patients received an energy therapy called Reiki. Reiki was administered to cancer patients for four consecutive days at specified times. During this procedure, while the patient was in the supine position, the researcher's hands were placed approximately two to three centimeters above the chakra regions of the patient, covering the seven chakra areas as well as the areas experiencing pain. The application lasted a total of 25-30 minutes. Silence was maintained in the patient's room during the intervention. Receives: Other: Reiki |
| Sham Reiki | Sham comparator | In the placebo group, patients received Sham Reiki. Sham Reiki was administered to cancer patients for four consecutive days at specified times. During this procedure, while the patient was in the supine position, Sham Reiki practitioner's hands were placed approximately two to three centimeters above the chakra regions of the patient, covering the seven chakra areas as well as the areas experiencing pain. The application lasted a total of 25-30 minutes. Silence was maintained in the patient's room during the intervention. Receives: Other: Sham Reiki |
| Progressive Relaxation Exercise | Active comparator | Silence was maintained in the patient's room during the intervention. At the beginning of the session, the patient is asked to assume the most comfortable seated or supine position. Then, they are instructed to close their eyes, take deep breaths, direct their thoughts to their own body and the muscle groups being treated, notice the tension and relaxation in the muscle groups during the exercise, and continue to breathe regularly. This practice was conducted in four parts of the body: hands and arms; face and shoulders; chest, abdomen, hips; legs and feet. Receives: Other: Progressive Relaxation Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress levels
Stress levels of the patients was measured by Perceived Stress Scale and serum cortisol levels. The 14-item five-point Likert-type scale consists of two factors. The lowest score a participant can obtain from this scale is 0 and the highest score is 56. A high score indicates that the person's perception of stress is high. A high total score means that the perceived stress level is high. As a result of the score between 0-35, it can be said that the participants are in a positive stress level, they can cope with stress effectively and the coping mechanisms they use are functional. It can be said that the methods used by the participants with a score range between 36-56 are not functional, that is, they cannot cope with stress effectively. Prior to initiating the interventions, blood samples were obtained from the patients to assess serum cortisol levels; on the twenty-first day follow-up, they were reassessed before the commencement of medical treatment.
Measured: In the pre-test and on the 21st-day follow-up
Secondary outcomes (2)
Anxiety levels
Anxiety level of the patients was evaluated with 0-10 Likert-type scale and State Anxiety Inventory (STAI-S). Anxiety level of the patients was evaluated with 0-10 Likert-type scale and State Anxiety Inventory (STAI-S). The original form was designed by Spielberger et al. (1970) to determine the state and trait anxiety levels of individuals separately. The scale can be administered to individuals aged 14 years and older. There are 20 items in the scale and the scale provides information about the anxiety level of the patient. There are ten inverted statements in the scale
Measured: In the pre-test, on the 4th-day, on the 21st-day and 3rd month
Pain levels
The pain level of the patients was evaluated with a 0-10 Likert-type scale called Visual Analogue Scale (VAS). The VAS is a scale used to determine the level of pain between "0: no pain" and "10: unbearable pain". VAS is considered a reliable and valid measurement tool in repeated measurements. It is used to assess the severity of acute pain. It has been noted to have higher sensitivity compared to other methods in evaluating pain severity.
Measured: In the pre-test, on the 4th-day, on the 21st-day and 3rd month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start2 Sep 2022
- Primary completion30 Nov 2022
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Therapeutic TouchStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- This study is a three-arm intervention trial. Reiki was applied to the intervention group, Sham Reiki to the placebo group, and Progressive Relaxation Exercise to the control group. The effects of these three methods applied to cancer patients on their levels of pain, anxiety, and cortisol were examined.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevcan Oz Kahveci, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06296680
- Sponsor's protocol ID
- EGE_UNI_SEVCAN_OZ_KAHVECI_0001
- Status last verified
- Feb 2024
- First submitted
- 29 Feb 2024
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Reiki Applied to Cancer Patients on Pain, Anxiety, and Stress Levels: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06296680
- Acronym / sponsor ID
- EGE_UNI_SEVCAN_OZ_KAHVECI_0001
- Conditions
- Therapeutic Touch, Cancer
- Keywords
- Reiki, Cancer, Pain, Anxiety, Stress, Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 2 Sep 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 6 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- This study is a three-arm intervention trial. Reiki was applied to the intervention group, Sham Reiki to the placebo group, and Progressive Relaxation Exercise to the control group. The effects of these three methods applied to cancer patients on their levels of pain, anxiety, and cortisol were examined.
| Arm | Type | Receives |
|---|---|---|
| Reiki | Experimental | Other: ReikiIn the intervention group, patients received an energy therapy called Reiki. Reiki was administered to cancer patients for four consecutive days at specified times. During this procedure, while the patient was in the supine position, the researcher's hands were placed approximately two to three centimeters above the chakra regions of the patient, covering the seven chakra areas as well as the areas experiencing pain. The application lasted a total of 25-30 minutes. Silence was maintained in the patient's room during the intervention. |
| Sham Reiki | Sham comparator | Other: Sham ReikiIn the placebo group, patients received Sham Reiki. Sham Reiki was administered to cancer patients for four consecutive days at specified times. During this procedure, while the patient was in the supine position, Sham Reiki practitioner's hands were placed approximately two to three centimeters above the chakra regions of the patient, covering the seven chakra areas as well as the areas experiencing pain. The application lasted a total of 25-30 minutes. Silence was maintained in the patient's room during the intervention. |
| Progressive Relaxation Exercise | Active comparator | Other: Progressive Relaxation ExerciseSilence was maintained in the patient's room during the intervention. At the beginning of the session, the patient is asked to assume the most comfortable seated or supine position. Then, they are instructed to close their eyes, take deep breaths, direct their thoughts to their own body and the muscle groups being treated, notice the tension and relaxation in the muscle groups during the exercise, and continue to breathe regularly. This practice was conducted in four parts of the body: hands and arms; face and shoulders; chest, abdomen, hips; legs and feet. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Conscious
- Aged 18 and over
- Without serious mental disorders (Bipolar Disorder, Schizophrenia, Schizoaffective Disorder, Major Depression, Personality Disorders)
- Without visual and hearing impairments
- Capable of verbal communication
Key exclusion criteria (1 listed)
- Patients using cortisol were not included in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReikiThe patients in the intervention group received Reiki to the seven chakra regions and additional areas with pain for a total duration of 25-30 minutes for four consecutive days. On the 4th day, pain and anxiety levels of the patients were evaluated after the last applications. On the 21st day, 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, state anxiety scale and perceived stress scale were evaluated. | Other | Reiki |
| Sham ReikiThe patients in the placebo group received Sham Reiki to the seven chakra regions for a total duration of 25-30 minutes for four consecutive days. On the 4th day, pain and anxiety levels of the patients were evaluated after the last applications. On the 21st day, 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, state anxiety scale and perceived stress scale were evaluated. | Other | Sham Reiki |
| Progressive Relaxation ExerciseAlso: the patients in the control group received Progressive Relaxation Exercise.PRE group patients received PRE for four consecutive days. On the 4th day, pain and anxiety levels of the patients were evaluated after the last applications. On the 21st day, 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, state anxiety scale and perceived stress scale were evaluated. | Other | Progressive Relaxation Exercise |
Primary outcome
Stress levels
Time frame: In the pre-test and on the 21st-day follow-up
Stress levels of the patients was measured by Perceived Stress Scale and serum cortisol levels. The 14-item five-point Likert-type scale consists of two factors. The lowest score a participant can obtain from this scale is 0 and the highest score is 56. A high score indicates that the person's perception of stress is high. A high total score means that the perceived stress level is high. As a result of the score between 0-35, it can be said that the participants are in a positive stress level, they can cope with stress effectively and the coping mechanisms they use are functional. It can be said that the methods used by the participants with a score range between 36-56 are not functional, that is, they cannot cope with stress effectively. Prior to initiating the interventions, blood samples were obtained from the patients to assess serum cortisol levels; on the twenty-first day follow-up, they were reassessed before the commencement of medical treatment.
2 secondary outcomes
Anxiety levels
Time frame: In the pre-test, on the 4th-day, on the 21st-day and 3rd month
Pain levels
Time frame: In the pre-test, on the 4th-day, on the 21st-day and 3rd month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reiki and Progressive Relaxation Exercise in people with Therapeutic Touch and Cancer, run by Ege University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress levels (time frame: In the pre-test and on the 21st-day follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.