İntensive CareNCT06526949
The Effect of Reiki on Pain, Anxiety and Haemodynamic Parameters in Patients Receiving Mechanical Ventilator Support
A study testing Reiki in people with İntensive Care and Nursing, run by University of Yalova at 1 site in Turkey (Türkiye).
Trial summary
Patients receiving mechanical ventilation (MV) support in intensive care units (ICU) may have some negative experiences. The most common of these are problems such as pain, agitation, anxiety, deterioration in comfort, dry mouth, thirst, and inadequacy in communication. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- İntensive Care, Nursing, Reiki
- What is being tested?
- Reiki
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Aug 2024to 30 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- over 18 years of age,
- not have a neurological and psychiatric diagnosis,
- are not due to drug/alcohol etc. intoxication,
- are not in the terminal period, who are not sedated,
- have a GCS score of 9 and above, who receive mechanical ventilation support for more than 48 hours,
- haemodynamically stable (not on high dose inotrope support, etc.),
- have a pain score of 3 and above.
Who cannot join
- Patients who do not fulfil the inclusion criteria will be excluded.
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bursa Training and Research Hospital
Bursa, Yıldırım, 16059
About this study
Official title: The Effect of Reiki on Pain, Anxiety and Haemodynamic Parameters in Patients Receiving Mechanical Ventilator Support: A Randomised, Single-Blinded and Placebo-Controlled Study
Patients receiving mechanical ventilation (MV) support in intensive care units (ICU) may have some negative experiences. The most common of these are problems such as pain, agitation, anxiety, deterioration in comfort, dry mouth, thirst, and inadequacy in communication.
Reiki, one of the energy therapies among the non-pharmacological nursing practices that have become widespread in recent years, is one of the healing therapies that contribute to the protection and promotion of well-being, healthy aging, and the treatment of some health deviations and is applied noninvasively with hands.
In the literature, there are many studies suggesting that Reiki has positive effects on pain, anxiety and stress response (heart rate, blood pressure, respiratory rate) in patients with Reiki. It is known that these studies generally consist of health professionals such as cancer, haemodialysis, patients undergoing laparoscopic or endoscopic procedures, haemodialysis patients or nurses. Studies have shown that Reiki is especially effective in cancer patients, preoperative stress, anxiety, postoperative pain and symptom management in chronic diseases. For Reiki application in the intensive care unit, only a few studies conducted in the neonatal intensive care unit were found.
Read the detailed description
The study will consist of 40 patients hospitalized in intensive care units of Yalova Training and Research Hospital and who are receiving mechanical ventilation treatment. The sample will consist of patients who receive mechanical ventilation support in the intensive care unit, who are over 18 years of age, who are willing to participate in the study, who do not have neurological and psychiatric diagnoses, who are not due to drug/alcohol etc. intoxication, who are not in the terminal period, who are not sedated, who have a Glasgow Coma Scale (GCS) score of 9 and above, who are receiving mechanical ventilation support for more than 48 hours, who are hemodynamically stable (not on high dose inotropic support, etc.), and who have a pain score of 3 and above.
Since there was no previous study similar to our research in the literature, the sample size was calculated as 26 patients in the experimental group and 26 patients in the control group with a large effect size d= 0.8, 5% margin of error (α) and statistical power (1-β) = 0.80 as recommended. To increase the power of the study and assume that there may be losses from the sample group, 30 patients were planned to be included in the study, 30 in the experimental group and 30 in the control group.
- Conditions
- İntensive Care, Nursing, Reiki
- Being tested
- Reiki, (Sham Reiki)
- Keywords
- Reiki, Critical care, İntensive care, Nursing care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReikiBehavioural
Reiki application was performed by a responsible researcher who has a Level 3 (Reiki Master) certificate. To prevent contamination between patients and to provide a suitable environment during the intervention, a curtain-screen system was used in the intensive care unit, and patients were fitted with earplugs to provide a quiet environment during the procedure. During the treatment (total time 30 minutes) the Reiki practitioner gently placed his/her hands on or above the patient's head and eyes, upper body from neck to pelvic area, arms and legs (standard Reiki hand positions). The application was limited and performed once due to the rapid changes in intubation time, intensive care unit stay and hemodynamic stability.
(Sham Reiki)Other
n the placebo (sham Reiki) group, treatments were performed by sham practitioners (not involved in the study) who had no experience with energy work and did not believe in energy therapy. In order to ensure blinding during the sham application, the patients were given the same hand movements as the experimental group for the same duration. In order not to distract the patients during the application, the area was separated with a curtain and screen system and earplugs were used. The sham practitioner gently placed his hands on or above the patient's head and eyes, upper body from the neck to the pelvic area, arms and legs for 30 minutes. The application was simulated in a manner similar to standard Reiki hand positions.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Reiki application was performed by a responsible researcher who has a Level 3 (Reiki Master) certificate. To prevent contamination between patients and to provide a suitable environment during the intervention, a curtain-screen system was used in the intensive care unit, and patients were fitted with earplugs to provide a quiet environment during the procedure. During the treatment (total time 30 minutes) the Reiki practitioner gently placed his/her hands on or above the patient's head and eyes, upper body from neck to pelvic area, arms and legs (standard Reiki hand positions). The application was limited and performed once due to the rapid changes in intubation time, intensive care unit stay and haemodynamic stability. Receives: Behavioral: Reiki |
| Placebo Control Group: | Placebo comparator | In the placebo (sham Reiki) group, treatments were performed by sham practitioners (not involved in the study) who had no experience with energy work and did not believe in energy therapy. To ensure blinding during the sham application, patients received the same hand movements as the experimental group for the same duration. To minimize distractions to the patients during the application, the area was separated by a curtain and screen system, and earplugs were used. The sham practitioner gently placed his hands on or above the patient's head and eyes, upper body from the neck to the pelvic area, arms and legs for 30 minutes. The application was simulated like standard Reiki hand positions. Receives: Other: (Sham Reiki) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain score measured by the Intensive Care Pain Observation Tool (CPOT) in patients receiving mechanical ventilation support
Intensive Care Pain Observation Scale (CPOT): This scale was developed to diagnose pain in ICU patients. The scale consists of four subscales expressing behavioural items such as facial expression, body movements, muscle tension and compliance with ventilation for intubated patients or sounds for extubated patients. Three points and above are considered as pain. Each of the sections is evaluated between 0-2 points and The CPOT score ranges from 0-8; higher scores indicate more pain. The scale assesses facial expression, body movements, muscle tension, and compliance with ventilation.
Measured: Baseline and immediately after intervention
Secondary outcomes (5)
Change in analgesic requirements
Analgesic dose or request recorded from ICU records during and up to 1 hour after intervention.
Measured: During the 30-minute intervention and 30 minutes post-intervention (total 1 hour)
Change in systolic and diastolic blood pressure
Blood pressure (mmHg) measured using standard ICU monitors at baseline and immediately post-intervention.
Measured: Baseline and immediately after intervention
Change in heart rate
Heart rate (beats per minute) measured using standard ICU monitors at baseline and immediately post-intervention.
Measured: Baseline and immediately after intervention
Change in respiratory rate
Respiratory rate (breaths per minute) measured using standard ICU monitors at baseline and immediately post-intervention.
Measured: Baseline and immediately after intervention
Change in anxiety score measured by the Face Anxiety Scale (FAS)
Anxiety level was assessed using the Face Anxiety Scale (FAS), which ranges from 1 (no anxiety) to 5 (severe anxiety) based on five standardized facial expressions. The scale has been validated for use in intensive care patients.
Measured: Baseline and immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start10 Aug 2024
- Primary completion10 Sep 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for İntensive CareStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Reiki application was performed by a responsible researcher who has a Level 3 (Reiki Master) certificate. To prevent contamination between patients and to provide a suitable environment during the intervention, a curtain-screen system was used in the intensive care unit, and patients were fitted with earplugs to provide a quiet environment during the procedure. During the treatment (total time 30 minutes) the Reiki practitioner gently placed his/her hands on or above the patient's head and eyes, upper body from neck to pelvic area, arms and legs (standard Reiki hand positions).ion time, intensive care unit stay and hemodynamic stability. Placebo Control Group In the placebo (sham Reiki) group, treatments were performed by sham practitioners (not involved in the study) who had no experience with energy work and did not believe in energy therapy.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Yalova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin Karacan, University of Yalova
- Investigators
- Yasemin Karacan, Principal investigator, University of Yalova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06526949
- Sponsor's protocol ID
- YKaracan
- Status last verified
- Aug 2025
- First submitted
- 5 Jul 2024
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The results of the study will be presented after the end of the study.
Publications
Gokdere Cinar H, Alpar S, Ilhan S. Evaluation of the Impacts of Reiki Touch Therapy on Patients Diagnosed With Fibromyalgia Who Are Followed in the Pain Clinic. Holist Nurs Pract. 2023 May-Jun 01;37(3):161-171. doi: 10.1097/HNP.0000000000000497. Epub 2022 Jan 31.
PubMed 37070840Karacan Y, Parlak AG, Ertem AC. Effect of Reiki on Pain, Anxiety, and Hemodynamic Parameters in Mechanically Ventilated Patients: A Randomized, Single-Blind, and Placebo-Controlled Trial. J Integr Complement Med. 2026 Feb;32(2):165-173. doi: 10.1177/27683605251384808. Epub 2026 Feb 18.
PubMed 41051913
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Reiki on Pain, Anxiety and Haemodynamic Parameters in Patients Receiving Mechanical Ventilator Support: A Randomised, Single-Blinded and Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT06526949
- Acronym / sponsor ID
- YKaracan
- Conditions
- İntensive Care, Nursing, Reiki
- Keywords
- Reiki, Critical care, İntensive care, Nursing care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of YalovaUniversity, hospital or other
- Study start
- 10 Aug 2024 (actual)
- Primary completion
- 10 Sep 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 30 Jul 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.
Patients receiving mechanical ventilation (MV) support in intensive care units (ICU) may have some negative experiences. The most common of these are problems such as pain, agitation, anxiety, deterioration in comfort, dry mouth, thirst, and inadequacy in communication.
Reiki, one of the energy therapies among the non-pharmacological nursing practices that have become widespread in recent years, is one of the healing therapies that contribute to the protection and promotion of well-being, healthy aging, and the treatment of some health deviations and is applied noninvasively with hands.
In the literature, there are many studies suggesting that Reiki has positive effects on pain, anxiety and stress response (heart rate, blood pressure, respiratory rate) in patients with Reiki. It is known that these studies generally consist of health professionals such as cancer, haemodialysis, patients undergoing laparoscopic or endoscopic procedures, haemodialysis patients or nurses. Studies have shown that Reiki is especially effective in cancer patients, preoperative stress, anxiety, postoperative pain and symptom management in chronic diseases. For Reiki application in the intensive care unit, only a few studies conducted in the neonatal intensive care unit were found.
Detailed description
The study will consist of 40 patients hospitalized in intensive care units of Yalova Training and Research Hospital and who are receiving mechanical ventilation treatment. The sample will consist of patients who receive mechanical ventilation support in the intensive care unit, who are over 18 years of age, who are willing to participate in the study, who do not have neurological and psychiatric diagnoses, who are not due to drug/alcohol etc. intoxication, who are not in the terminal period, who are not sedated, who have a Glasgow Coma Scale (GCS) score of 9 and above, who are receiving mechanical ventilation support for more than 48 hours, who are hemodynamically stable (not on high dose inotropic support, etc.), and who have a pain score of 3 and above.
Since there was no previous study similar to our research in the literature, the sample size was calculated as 26 patients in the experimental group and 26 patients in the control group with a large effect size d= 0.8, 5% margin of error (α) and statistical power (1-β) = 0.80 as recommended. To increase the power of the study and assume that there may be losses from the sample group, 30 patients were planned to be included in the study, 30 in the experimental group and 30 in the control group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Reiki application was performed by a responsible researcher who has a Level 3 (Reiki Master) certificate. To prevent contamination between patients and to provide a suitable environment during the intervention, a curtain-screen system was used in the intensive care unit, and patients were fitted with earplugs to provide a quiet environment during the procedure. During the treatment (total time 30 minutes) the Reiki practitioner gently placed his/her hands on or above the patient's head and eyes, upper body from neck to pelvic area, arms and legs (standard Reiki hand positions).ion time, intensive care unit stay and hemodynamic stability. Placebo Control Group In the placebo (sham Reiki) group, treatments were performed by sham practitioners (not involved in the study) who had no experience with energy work and did not believe in energy therapy.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: ReikiReiki application was performed by a responsible researcher who has a Level 3 (Reiki Master) certificate. To prevent contamination between patients and to provide a suitable environment during the intervention, a curtain-screen system was used in the intensive care unit, and patients were fitted with earplugs to provide a quiet environment during the procedure. During the treatment (total time 30 minutes) the Reiki practitioner gently placed his/her hands on or above the patient's head and eyes, upper body from neck to pelvic area, arms and legs (standard Reiki hand positions). The application was limited and performed once due to the rapid changes in intubation time, intensive care unit stay and haemodynamic stability. |
| Placebo Control Group: | Placebo comparator | Other: (Sham Reiki)In the placebo (sham Reiki) group, treatments were performed by sham practitioners (not involved in the study) who had no experience with energy work and did not believe in energy therapy. To ensure blinding during the sham application, patients received the same hand movements as the experimental group for the same duration. To minimize distractions to the patients during the application, the area was separated by a curtain and screen system, and earplugs were used. The sham practitioner gently placed his hands on or above the patient's head and eyes, upper body from the neck to the pelvic area, arms and legs for 30 minutes. The application was simulated like standard Reiki hand positions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- over 18 years of age,
- not have a neurological and psychiatric diagnosis,
- are not due to drug/alcohol etc. intoxication,
- are not in the terminal period, who are not sedated,
- have a GCS score of 9 and above, who receive mechanical ventilation support for more than 48 hours,
Key exclusion criteria (2 listed)
- Patients who do not fulfil the inclusion criteria will be excluded.
- -
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 |
|---|---|---|
| ReikiReiki application was performed by a responsible researcher who has a Level 3 (Reiki Master) certificate. To prevent contamination between patients and to provide a suitable environment during the intervention, a curtain-screen system was used in the intensive care unit, and patients were fitted with earplugs to provide a quiet environment during the procedure. During the treatment (total time 30 minutes) the Reiki practitioner gently placed his/her hands on or above the patient's head and eyes, upper body from neck to pelvic area, arms and legs (standard Reiki hand positions). The application was limited and performed once due to the rapid changes in intubation time, intensive care unit stay and hemodynamic stability. | Behavioural | Intervention group |
| (Sham Reiki)n the placebo (sham Reiki) group, treatments were performed by sham practitioners (not involved in the study) who had no experience with energy work and did not believe in energy therapy. In order to ensure blinding during the sham application, the patients were given the same hand movements as the experimental group for the same duration. In order not to distract the patients during the application, the area was separated with a curtain and screen system and earplugs were used. The sham practitioner gently placed his hands on or above the patient's head and eyes, upper body from the neck to the pelvic area, arms and legs for 30 minutes. The application was simulated in a manner similar to standard Reiki hand positions. | Other | Placebo Control Group: |
Primary outcome
Change in pain score measured by the Intensive Care Pain Observation Tool (CPOT) in patients receiving mechanical ventilation support
Time frame: Baseline and immediately after intervention
Intensive Care Pain Observation Scale (CPOT): This scale was developed to diagnose pain in ICU patients. The scale consists of four subscales expressing behavioural items such as facial expression, body movements, muscle tension and compliance with ventilation for intubated patients or sounds for extubated patients. Three points and above are considered as pain. Each of the sections is evaluated between 0-2 points and The CPOT score ranges from 0-8; higher scores indicate more pain. The scale assesses facial expression, body movements, muscle tension, and compliance with ventilation.
5 secondary outcomes
Change in analgesic requirements
Time frame: During the 30-minute intervention and 30 minutes post-intervention (total 1 hour)
Change in systolic and diastolic blood pressure
Time frame: Baseline and immediately after intervention
Change in heart rate
Time frame: Baseline and immediately after intervention
Change in respiratory rate
Time frame: Baseline and immediately after intervention
Change in anxiety score measured by the Face Anxiety Scale (FAS)
Time frame: Baseline and immediately after intervention
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 8 Aug 2025.
- Results publication: PubMed 37070840Gokdere Cinar H, Alpar S, Ilhan S. Evaluation of the Impacts of Reiki Touch Therapy on Patients Diagnosed With Fibromyalgia Who Are Followed in the Pain Clinic. Holist Nurs Pract. 2023 May-Jun 01;37(3):161-171. doi: 10.1097/HNP.0000000000000497. Epub 2022 Jan 31.
- Derived from this study: PubMed 41051913Karacan Y, Parlak AG, Ertem AC. Effect of Reiki on Pain, Anxiety, and Hemodynamic Parameters in Mechanically Ventilated Patients: A Randomized, Single-Blind, and Placebo-Controlled Trial. J Integr Complement Med. 2026 Feb;32(2):165-173. doi: 10.1177/27683605251384808. Epub 2026 Feb 18.
- Individual participant dataSharing planned: Yes. The results of the study will be presented after the end of the study.
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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.
Yasemin Karacan principal investigator
University of Yalova
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 in people with İntensive Care and Nursing, run by University of Yalova 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 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 8 Aug 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?
Change in pain score measured by the Intensive Care Pain Observation Tool (CPOT) in patients receiving mechanical ventilation support (time frame: Baseline and immediately after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06526949, which also lists 2 linked publications.
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 8 Aug 2025.