Fatigue and Sleep Quality in Multiple Sclerosis Patients

Fatigue and Sleep Quality in Multiple Sclerosis Patients: Does Reiki Application Affect?

This study was planned to examine the effect of reiki application on fatigue and sleep quality in patients with multiple sclerosis.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: Reiki

Detailed Description

Fatigue and Sleep Quality in Multiple Sclerosis Patients: Does Reiki Application Affect?

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

Contacts and Locations

Study Locations

• Turkey
  • Güneydoğu Anadolu Bölgesi
    • Istanbul, Güneydoğu Anadolu Bölgesi, Turkey, 340340
      • Istanbul Sabahattin Zaim University, Faculty of Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Being over 18 years old
• Volunteering to participate in the research
• Having the ability to use technological tools
• Not using Reiki and similar integrative treatment methods
• Not having a verbal communication disability (hearing and speaking)
• Not having a diagnosed psychiatric disorder
• Patients who have been treated for MS for more than three months
• Having a scale score of >5 on the Piper Fatigue Scale
• A score of >5 on the Pittsburgh Sleep Quality Scale

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Routine maintenance will be applied
Experimental: Reiki; The researcher, a second-degree Reiki therapist, performed the Reiki therapy. Patients were told to lie comfortably on their backs after they were informed about the therapy. Each of the 7 Reiki hand positions was applied sequentially. Each of the hand positions took 2-3 minutes, requiring 30-40 minutes in total.	Other: Reiki; Reiki is applied touching the energy centers of the body (chakras). There are seven main and many small chakras on a body. Chakras are located on the front and back sides of the body in a vertical line that runs along the middle of the body in humans. A complete Reiki therapy includes all the chakras and organs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Piper Fatigue Scale	It is a 22-item scale that measures four subscales: behavior (6 items), affect (5 items), sensory (5 items), and cognition/mood (6 items). Each item has 11 response categories on a 0-10 metric with verbal descriptors anchoring the endpoints. Each subscale is scored individually and then aggregated together for an overall score, with higher scores reflecting more fatigue.	At the end of Session 1(In the first week, the first session will be face-to-face and the other sessions will be online for 4 days. 1 online session will be given on the first day of the 2nd, 3rd and 4th week. A total of 7 sessions of Reiki will begiven)
The Piper Fatigue Scale	It is a 22-item scale that measures four subscales: behavior (6 items), affect (5 items), sensory (5 items), and cognition/mood (6 items). Each item has 11 response categories on a 0-10 metric with verbal descriptors anchoring the endpoints. Each subscale is scored individually and then aggregated together for an overall score, with higher scores reflecting more fatigue.	At the end of Session 7(In the first week, the first session will be face-to-face and the other sessions will be online for 4 days. 1 online session will be given on the first day of the 2nd, 3rd and 4th week. A total of 7 sessions of Reiki will begiven)
Pittsburgh Sleep Quality Index (PSQI)	The PSQI is a valid and consistent survey comprising of 19 questions to assess quality and amount of sleep and the existence of a sleep disorder and its level in the previous month. The scale was adapted into the Turkish language by Agargün et al. (1996). The scale consists of seven components that assess patients subjective sleep quality, sleep delay, use of sleeping medication and disfunction in daily activities. Each item scores in the range 0-3 points and the total score of the seven components gives the total PSQI score. The total score has a value between 0-21 and a high total score demonstrates a poor quality of sleep. A total PSQI score which is ≤5 indicates "good sleep", and a score which is >5 indicates "poor sleep"	At the end of Session 1(In the first week, the first session will be face-to-face and the other sessions will be online for 4 days. 1 online session will be given on the first day of the 2nd, 3rd and 4th week. A total of 7 sessions of Reiki will begiven)
Pittsburgh Sleep Quality Index (PSQI)	The PSQI is a valid and consistent survey comprising of 19 questions to assess quality and amount of sleep and the existence of a sleep disorder and its level in the previous month. The scale was adapted into the Turkish language by Agargün et al. (1996). The scale consists of seven components that assess patients subjective sleep quality, sleep delay, use of sleeping medication and disfunction in daily activities. Each item scores in the range 0-3 points and the total score of the seven components gives the total PSQI score. The total score has a value between 0-21 and a high total score demonstrates a poor quality of sleep. A total PSQI score which is ≤5 indicates "good sleep", and a score which is >5 indicates "poor sleep"	At the end of Session 7(In the first week, the first session will be face-to-face and the other sessions will be online for 4 days. 1 online session will be given on the first day of the 2nd, 3rd and 4th week. A total of 7 sessions of Reiki will begiven)

Collaborators and Investigators

• Sponsor: Istanbul Sabahattin Zaim University
• Investigators: Study Director: Zülfünaz Özer, PhD, Istanbul Sabahattin Zaim University

Publications and helpful links

General Publications

• Demir M, Can G, Kelam A, Aydiner A. Effects of Distant Reiki On Pain, Anxiety and Fatigue in Oncology Patients in Turkey: A Pilot Study. Asian Pac J Cancer Prev. 2015;16(12):4859-62. doi: 10.7314/apjcp.2015.16.12.4859.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): August 8, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: July 5, 2022
• First Submitted That Met QC Criteria: July 12, 2022
• First Posted (Actual): July 13, 2022

Study Record Updates

• Last Update Posted (Actual): August 31, 2023
• Last Update Submitted That Met QC Criteria: August 30, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Fatigue; Reiki; Nursing; Sleep quality
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Fatigue
• Other Study ID Numbers: 6812

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No