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

Not Applicable

Completed

• Conditions: Nursing; İntensive Care; Reiki

• Registration Number: NCT06526949
• Lead Sponsor: University of Yalova

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.

Study Timeline

• Study First Submitted: 2024-07-05
• Study First Submitted QC: 2024-07-26
• Study First Posted: 2024-07-30
• Study Start: 2024-08-10
• Primary Completion: 2024-09-10
• Study Completion: 2024-10-30
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-07
• Last Update Posted: 2025-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in pain score measured by the Intensive Care Pain Observation Tool (CPOT) in patients receiving mechanical ventilation support	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.

Secondary Outcome Measures

Name	Time	Method
Change in analgesic requirements	During the 30-minute intervention and 30 minutes post-intervention (total 1 hour)	Analgesic dose or request recorded from ICU records during and up to 1 hour after intervention.
Change in respiratory rate	Baseline and immediately after intervention	Respiratory rate (breaths per minute) measured using standard ICU monitors at baseline and immediately post-intervention.
Change in systolic and diastolic blood pressure	Baseline and immediately after intervention	Blood pressure (mmHg) measured using standard ICU monitors at baseline and immediately post-intervention.
Change in heart rate	Baseline and immediately after intervention	Heart rate (beats per minute) measured using standard ICU monitors at baseline and immediately post-intervention.
Change in anxiety score measured by the Face Anxiety Scale (FAS)	Baseline and immediately after intervention	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.

Trial Locations

Locations (1)

Bursa Training and Research Hospital; 🇹🇷 Bursa, Yıldırım, Turkey