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

Not Applicable

Not yet recruiting

• Conditions: Nursing; İntensive Care; Reiki
• Interventions: Other: (Sham Reiki); Behavioral: 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 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

• Status Verified: 2024-07
• Study First Submitted: 2024-07-05
• Study First Submitted QC: 2024-07-26
• Last Update Submitted: 2024-07-26
• Study First Posted: 2024-07-30
• Last Update Posted: 2024-07-30
• Study Start: 2024-08-15
• Primary Completion: 2024-11-10
• Study Completion: 2024-12-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• 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

Arm && Interventions

Group	Intervention	Description
Placebo Control Group:	(Sham Reiki)	In the sham (Sham Reiki) group, sham practitioners (not involved in the study) who have no experience in energy work will prepare screens and headphones for the patients as in the intervention group. Then, they will place their hands gently on or above the patient's head and eyes, upper body from the neck to the pelvic region, arms and legs (standard reiki hand positions) for 30 minutes every other day for 2 days in a row or 2 times (Day 1 and Day 3) like the practitioner in the intervention group. Patient data will be recorded on forms before and after placebo administration as in the intervention group.
Intervention group	Reiki	Reiki application will be applied to the patients for 2 consecutive days or 2 times (1st and 3rd day) for 30 minutes every other day. Pain, anxiety and haemodynamic parameters will be recorded on data collection forms before and at the end of the application. The duration of intubation, intensive care unit stay and haemodynamic stability of the patients will be limited due to the rapid changes.

Primary Outcome Measures

Name	Time	Method
Reiki has an effect on pain level in patients receiving mechanical ventilation support.	1 year	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 total score varies between min:0-max:8.

Trial Locations

Locations (1)

Yalova Training and Research Hospital; 🇹🇷 Yalova, Çınarcık, Turkey