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

NCT06526949 | Completed

• 1 other identifier: YKaracan
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

İntensive Care; Nursing; Reiki

Keywords

Reiki; Critical care; İntensive care; Nursing care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in analgesic requirements

  During the 30-minute intervention and 30 minutes post-intervention (total 1 hour)

• Change in systolic and diastolic blood pressure

  Baseline and immediately after intervention

• Change in heart rate

  Baseline and immediately after intervention

• Change in respiratory rate

  Baseline and immediately after intervention

• Change in anxiety score measured by the Face Anxiety Scale (FAS)

  Baseline and immediately after intervention

Study Arms (2)

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.

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.

Other: (Sham Reiki)

Interventions

Reiki 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.

Intervention group

(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.

Placebo Control Group:

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Yalova: lead

Study Sites (1)

Bursa Training and Research Hospital

Bursa, Yıldırım, 16059, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 37070840 BACKGROUND

• 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.

  PMID: 41051913 DERIVED

MeSH Terms

Interventions

Therapeutic Touch

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies

Study Officials

• Yasemin Karacan

  University of Yalova

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: It will not be possible for the researcher to be blinded due to the Reiki application and data collection forms. Blinding in the study will be performed only at the assignment-randomisation stage. Patients will be assigned to the intervention and control groups by the third person (preferably the nurse in charge of intensive care) who is not involved in the research according to the random numbers table in the database sent by the statistician, in the order of group 1 and group 2, using the blinding method.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assis.Prof

Model Details: 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.

Study Record Dates

• First Submitted: July 5, 2024
• First Posted: July 30, 2024
• Study Start: August 10, 2024
• Primary Completion: September 10, 2024
• Study Completion: October 30, 2024
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: 07.2025
• Access Criteria: The results of the study will be presented after the end of the study.

Locations

TU (1)