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

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.

Study Overview

• Status: Completed
• Conditions: Nursing; Reiki; İntensive Care
• Intervention / Treatment: Behavioral: Reiki; Other: (Sham Reiki)

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Yıldırım
    • Bursa, Yıldırım, Turkey, 16059
      • Bursa Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Exclusion Criteria:

Patients who do not fulfil the inclusion criteria will be excluded.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
Placebo Comparator: 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.	Other: (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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and immediately after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in analgesic requirements	Analgesic dose or request recorded from ICU records during and up to 1 hour after intervention.	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.	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.	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.	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.	Baseline and immediately after intervention

Collaborators and Investigators

• Sponsor: University of Yalova
• Investigators: Principal Investigator: Yasemin Karacan, University of Yalova

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2024
• Primary Completion (Actual): September 10, 2024
• Study Completion (Actual): October 30, 2024

Study Registration Dates

• First Submitted: July 5, 2024
• First Submitted That Met QC Criteria: July 26, 2024
• First Posted (Actual): July 30, 2024

Study Record Updates

• Last Update Posted (Actual): August 8, 2025
• Last Update Submitted That Met QC Criteria: August 7, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Reiki; Critical care; Nursing care; İntensive care
• Other Study ID Numbers: YKaracan

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The results of the study will be presented after the end of the study.
• IPD Sharing Time Frame: 07.2025
• IPD Sharing Access Criteria: The results of the study will be presented after the end of the study.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No