The Effect of Reiki on Pain, Anxiety and Haemodynamic Parameters in Patients Receiving Mechanical Ventilator Support

NCT ID: NCT06526949

Last Updated: 2025-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-10
• Study Completion Date: 2024-10-30

Brief 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.

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.

Conditions

İntensive Care; Nursing; Reiki

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Intervention group

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.

Group Type: EXPERIMENTAL

Reiki

Intervention Type: BEHAVIORAL

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.

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. 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.

Group Type: PLACEBO_COMPARATOR

(Sham Reiki)

Intervention Type: 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.

Interventions

Reiki

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.

Intervention Type: BEHAVIORAL

(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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. over 18 years of age,

2. not have a neurological and psychiatric diagnosis,

3. are not due to drug/alcohol etc. intoxication,

4. are not in the terminal period, who are not sedated,

5. have a GCS score of 9 and above, who receive mechanical ventilation support for more than 48 hours,

6. haemodynamically stable (not on high dose inotrope support, etc.),

7. have a pain score of 3 and above.

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• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Yalova

OTHER

Sponsor Role: lead

Responsible Party

Yasemin Karacan

Assis.Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yasemin Karacan

Role: PRINCIPAL_INVESTIGATOR

University of Yalova

Locations

Bursa Training and Research Hospital

Bursa, Yıldırım, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 37070840 (View on PubMed)

Karacan 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. 2025 Oct 6. doi: 10.1177/27683605251384808. Online ahead of print.

Reference Type: DERIVED

PMID: 41051913 (View on PubMed)

Other Identifiers

YKaracan

Identifier Type: -

Identifier Source: org_study_id