Fatigue and Sleep Quality in Multiple Sclerosis Patients

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05456464
• Other study ID #: 6812
• Status: Completed
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: September 30, 2022

Study information

• Verified date: August 2023
• Source: Istanbul Sabahattin Zaim University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 30, 2022
• Est. primary completion date: August 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatigue
• Multiple Sclerosis
• Sclerosis

Intervention

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.

Locations

Country	Name	City	State
Turkey	Istanbul Sabahattin Zaim University, Faculty of Health Sciences	Istanbul	Güneydogu Anadolu Bölgesi

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Sabahattin Zaim University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)