Supportive CareNCT06134453
Evaluation of the Effect of Reiki on Surgical Fear and Anxiety in Laparoscopic Cholecystectomy; Randomized Controlled Study
A study of Supportive Care, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
surgical intervention; It is defined as an emergency or planned treatment method for the purpose of diagnosis, treatment and symptom reduction in cases of deformity, injury, and disease with hands and tools. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Supportive Care
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2024to 15 Oct 2024
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-65 age range,
- No vision-hearing problem,
- Able to communicate verbally
- No diagnosed psychiatric problem,
- No history or current history of substance use,
- will receive general anesthesia,
- ASA I, II
- Laparoscopic cholecystectomy was planned,
Who cannot join
- Patients who develop a serious complication after surgery (patients who may need respiratory support and close monitoring due to metabolic disorders, hypothermia, or hemodynamic instability)
- Patients who have previously received energy therapies such as Reiki Touch Therapy / Therapeutic Touch / Healing Touch
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Reiki on Surgical Fear and Anxiety
surgical intervention; It is defined as an emergency or planned treatment method for the purpose of diagnosis, treatment and symptom reduction in cases of deformity, injury, and disease with hands and tools. Although these interventions are practices aimed at protecting life, whether it is large or small, urgent or planned, it is both physiological and psychological trauma for the patient. The decision of surgical intervention may cause anxiety in individuals regardless of the type of surgical procedure. Fear of anesthesia, fear of death, possibility of postoperative complications, pain, changes in activities of daily living, loss of social life and loss of control may cause anxiety. Reiki, a complementary and alternative medicine (CAM) method, is a bioenergy based on the body's energy use and has been used for centuries in the prevention and treatment of certain diseases in various cultures. Reiki is thought to help balance the body's natural energy systems and reduce anxiety by transferring existing energy through the hands. Studies on the effectiveness of reiki, which is increasingly used worldwide and recommended as a treatment approach in health care, are insufficient. The aim of this study, which was planned as a three-group interventional randomized control, was to evaluate the effect of reiki on surgical fear and anxiety of patients who will undergo laparoscopic cholecystectomy.
Read the detailed description
The results of the power analysis using the Gpower 3.1.9.2 program, it was planned to have 16 patients in reiki, 16 patients in sham reiki, and 16 patients in the control group, and study groups were determined by simple randomization method. The research data were collected between November 2022 and September 2023 in the operating room waiting room, in a quiet single room. Pre-application, "Personal Information Form", "Surgical Fear Form" and Surgical Anxiety Form" was applied to 12 patients who met the study criteria with the permission of the ethics committee. Data were collected in the operating room waiting room before and after Reiki. After obtaining the patient's consent, the Personal Information Form, the Surgical Fear Scale, and the Surgical Anxiety Scale were applied and recorded. According to randomization, the patients in the reiki/sham reiki group were taken to a quiet single room, and reiki/sham reiki was applied for approximately 25-30 minutes. Reiki application was applied by a researcher who received Reiki Master level training, and sham Reiki was applied by a health professional who did not receive Reiki training. A written protocol is provided to both the Reiki practitioner and Sham Reiki practitioner describing hand positions, areas of practice, sequence, and times. The "Surgical Fear Scale" and "Surgical Anxiety Scale" were applied again 5 minutes after the end of the application. In the control group according to randomization. The "Personal Information Form" was recorded by applying the "Surgical Fear Scale" and the "Surgical Anxiety Scale". 30 minutes of the evaluation were recorded by repeating the "Surgical Fear Scale" and "Surgical Anxiety Scale".
- Conditions
- Supportive Care
- Being tested
- Reiki/Sham Reiki
- Keywords
- Cholecystectomy, Surgical Fear, Surgical Anxiety, Reiki
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reiki/Sham ReikiOther
Also called Control Group
Reiki will be applied to the patients by the research nurse who is at the Reiki master level. Sham Reiki will remain in the same position and for the same duration as if Reiki was performed by a healthcare professional who has not received Reiki training, but Reiki energy will not be given to the patient. No intervention will be made to the control group.
| Study group | Role | What they receive |
|---|---|---|
| Reiki | Experimental | According to randomization, patients in the reiki group will be taken to a quiet single room and reiki will be applied for approximately 25-30 minutes. Reiki practice will be applied by a researcher who has been trained at the Reiki Master level. Receives: Other: Reiki/Sham Reiki |
| Sham Reiki | Sham comparator | According to randomization, the patients in the sham reiki group were taken to a quiet single room and sham reiki was applied for approximately 25-30 minutes. will be applied. According to random distribution, patients in the sham reiki group will be taken to a quiet single room and sham reiki will be applied for approximately 25-30 minutes. Sham Reiki will be administered by a healthcare professional who has not received Reiki training. Their hands will remain in the same position and for the same duration as if they were actually doing Reiki, but Reiki energy will not be given to the patient. Receives: Other: Reiki/Sham Reiki |
| Control Group | No intervention | The control group will be given routine care in the pre-operative waiting room without any intervention, and the data collection tools will be applied at the same time as the experimental group, twice at 30-minute intervals. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of participants' surgical fear mean scores before and after Reiki application
In the "Surgical Fear Scale", the lowest score that can be obtained from the subscales is 0 and the highest score is 40. The lowest score of the scale is 0 and the highest is 80. A high score indicates that fear is high.
Measured: [Time Frame: day 0]
Comparison of participants' "Surgical Anxiety Scale" average scores before and after Reiki application
"The highest score that can be obtained from the Surgical Anxiety Scale is 80, and the lowest score is 20. The higher the total anxiety score, the higher the person's anxiety level is interpreted.
Measured: [Time Frame: day 0]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start15 Mar 2024
- Primary completion30 May 2024
- Study completion15 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Supportive CareStudies of the same condition, open and under way.
- More trials run by Cukurova 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
- Parallel groups
- Model description
- Reiki, Sham Reiki, Control Group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hamide Sisman, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06134453
- Sponsor's protocol ID
- HS312
- Status last verified
- Feb 2025
- First submitted
- 6 Aug 2023
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A decision will be made after the study is completed.
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Reiki on Surgical Fear and Anxiety
- ClinicalTrials.gov ID
- NCT06134453
- Acronym / sponsor ID
- HS312
- Conditions
- Supportive Care
- Keywords
- Cholecystectomy, Surgical Fear, Surgical Anxiety, Reiki
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 15 Oct 2024 (actual)
- First posted
- 18 Nov 2023 (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.
surgical intervention; It is defined as an emergency or planned treatment method for the purpose of diagnosis, treatment and symptom reduction in cases of deformity, injury, and disease with hands and tools. Although these interventions are practices aimed at protecting life, whether it is large or small, urgent or planned, it is both physiological and psychological trauma for the patient. The decision of surgical intervention may cause anxiety in individuals regardless of the type of surgical procedure. Fear of anesthesia, fear of death, possibility of postoperative complications, pain, changes in activities of daily living, loss of social life and loss of control may cause anxiety. Reiki, a complementary and alternative medicine (CAM) method, is a bioenergy based on the body's energy use and has been used for centuries in the prevention and treatment of certain diseases in various cultures. Reiki is thought to help balance the body's natural energy systems and reduce anxiety by transferring existing energy through the hands. Studies on the effectiveness of reiki, which is increasingly used worldwide and recommended as a treatment approach in health care, are insufficient. The aim of this study, which was planned as a three-group interventional randomized control, was to evaluate the effect of reiki on surgical fear and anxiety of patients who will undergo laparoscopic cholecystectomy.
Detailed description
The results of the power analysis using the Gpower 3.1.9.2 program, it was planned to have 16 patients in reiki, 16 patients in sham reiki, and 16 patients in the control group, and study groups were determined by simple randomization method. The research data were collected between November 2022 and September 2023 in the operating room waiting room, in a quiet single room. Pre-application, "Personal Information Form", "Surgical Fear Form" and Surgical Anxiety Form" was applied to 12 patients who met the study criteria with the permission of the ethics committee. Data were collected in the operating room waiting room before and after Reiki. After obtaining the patient's consent, the Personal Information Form, the Surgical Fear Scale, and the Surgical Anxiety Scale were applied and recorded. According to randomization, the patients in the reiki/sham reiki group were taken to a quiet single room, and reiki/sham reiki was applied for approximately 25-30 minutes. Reiki application was applied by a researcher who received Reiki Master level training, and sham Reiki was applied by a health professional who did not receive Reiki training. A written protocol is provided to both the Reiki practitioner and Sham Reiki practitioner describing hand positions, areas of practice, sequence, and times. The "Surgical Fear Scale" and "Surgical Anxiety Scale" were applied again 5 minutes after the end of the application. In the control group according to randomization. The "Personal Information Form" was recorded by applying the "Surgical Fear Scale" and the "Surgical Anxiety Scale". 30 minutes of the evaluation were recorded by repeating the "Surgical Fear Scale" and "Surgical Anxiety Scale".
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Reiki, Sham Reiki, Control Group
| Arm | Type | Receives |
|---|---|---|
| Reiki | Experimental | Other: Reiki/Sham ReikiAccording to randomization, patients in the reiki group will be taken to a quiet single room and reiki will be applied for approximately 25-30 minutes. Reiki practice will be applied by a researcher who has been trained at the Reiki Master level. |
| Sham Reiki | Sham comparator | Other: Reiki/Sham ReikiAccording to randomization, the patients in the sham reiki group were taken to a quiet single room and sham reiki was applied for approximately 25-30 minutes. will be applied. According to random distribution, patients in the sham reiki group will be taken to a quiet single room and sham reiki will be applied for approximately 25-30 minutes. Sham Reiki will be administered by a healthcare professional who has not received Reiki training. Their hands will remain in the same position and for the same duration as if they were actually doing Reiki, but Reiki energy will not be given to the patient. |
| Control Group | No intervention | –The control group will be given routine care in the pre-operative waiting room without any intervention, and the data collection tools will be applied at the same time as the experimental group, twice at 30-minute intervals. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18-65 age range,
- No vision-hearing problem,
- Able to communicate verbally
- No diagnosed psychiatric problem,
- No history or current history of substance use,
Key exclusion criteria (2 listed)
- Patients who develop a serious complication after surgery (patients who may need respiratory support and close monitoring due to metabolic disorders, hypothermia, or hemodynamic instability)
- Patients who have previously received energy therapies such as Reiki Touch Therapy / Therapeutic Touch / Healing Touch
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 |
|---|---|---|
| Reiki/Sham ReikiAlso: Control GroupReiki will be applied to the patients by the research nurse who is at the Reiki master level. Sham Reiki will remain in the same position and for the same duration as if Reiki was performed by a healthcare professional who has not received Reiki training, but Reiki energy will not be given to the patient. No intervention will be made to the control group. | Other | Reiki, Sham Reiki |
Primary outcome
Comparison of participants' surgical fear mean scores before and after Reiki application
Time frame: [Time Frame: day 0]
In the "Surgical Fear Scale", the lowest score that can be obtained from the subscales is 0 and the highest score is 40. The lowest score of the scale is 0 and the highest is 80. A high score indicates that fear is high.
Comparison of participants' "Surgical Anxiety Scale" average scores before and after Reiki application
Time frame: [Time Frame: day 0]
"The highest score that can be obtained from the Surgical Anxiety Scale is 80, and the lowest score is 20. The higher the total anxiety score, the higher the person's anxiety level is interpreted.
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 12 Feb 2025.
- Individual participant dataSharing planned: Undecided. A decision will be made after the study is completed.
Related trials for Supportive Care
Not yet recruiting
Patient-reported Outcomes-driven Supportive Care Navigation Among Hispanic/Latinx Cancer Patients
Cancer
Active, not recruiting
Respiratory Support and Treatment for Efficient and Cost-Effective Care
Bronchiolitis
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
RecruitingObservational study
Psychotherapy for Irritability in Youth: Comparing Active Treatment to Nonactive Psychoeducation Supportive Psychotherapy
Irritability, Disruptive Mood Dysregulation Disorder
Recruiting
Technology-Based Intervention Pilot Testing
Dementia, Elder Abuse
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 of Supportive Care, run by Cukurova 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 8 inclusion and 2 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 12 Feb 2025. 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?
Comparison of participants' surgical fear mean scores before and after Reiki application (time frame: [Time Frame: day 0]). The study lists 2 primary outcomes in all. 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 12 Feb 2025.