Clinical trial NCT06526949: The Effect of Reiki on Pain, Anxiety and Haemodynamic Parameters in Patients Receiving Mechanical Ventilator Support
Official title: The Effect of Reiki on Pain, Anxiety and Haemodynamic Parameters in Patients Receiving Mechanical Ventilator Support: A Randomised, Single-Blinded and Placebo-Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: İntensive Care
Nursing
Reiki
Keywords: Reiki
Critical care
İntensive care
Nursing care
Lead sponsor: University of Yalova
Sponsor class: OTHER
First posted: 2024-07-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention group: 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.

Placebo Control Group: 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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Exclusion Criteria:

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

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Primary outcomes:
measure: Reiki has an effect on pain level in patients receiving mechanical ventilation support.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Yalova
country: Turkey
facility: Yalova Training and Research Hospital
state: Çınarcık
Study officials:
affiliation: Yalova University
name: Yasemin Karacan
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.