Fatigue and Sleep Quality in Multiple Sclerosis Patients

Sponsor
Istanbul Sabahattin Zaim University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05456464
Collaborator
(none)
60
1
2
4
15.1

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Reiki
N/A

Detailed Description

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The research will be conducted as a randomized, experimental study with a pretest-posttest control group.The research will be conducted as a randomized, experimental study with a pretest-posttest control group.
Masking:
Single (Participant)
Masking Description:
Reiki and control group
Primary Purpose:
Supportive Care
Official Title:
Fatigue and Sleep Quality in Multiple Sclerosis Patients: Does Reiki Application Affect?
Actual Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Aug 8, 2022
Anticipated Study Completion Date :
Sep 30, 2022

Arms and Interventions

Arm Intervention/Treatment
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.

No Intervention: Control group

Routine maintenance will be applied

Outcome Measures

Primary Outcome Measures

  1. The Piper Fatigue Scale [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)]

    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.

  2. The Piper Fatigue Scale [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)]

    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.

  3. Pittsburgh Sleep Quality Index (PSQI) [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 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"

  4. Pittsburgh Sleep Quality Index (PSQI) [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)]

    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"

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istanbul Sabahattin Zaim University, Faculty of Health Sciences Istanbul Güneydoğu Anadolu Bölgesi Turkey 340340

Sponsors and Collaborators

  • Istanbul Sabahattin Zaim University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zülfünaz ÖZER, Investigator, Istanbul Sabahattin Zaim University
ClinicalTrials.gov Identifier:
NCT05456464
Other Study ID Numbers:
  • 6812
First Posted:
Jul 13, 2022
Last Update Posted:
Jul 13, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Zülfünaz ÖZER, Investigator, Istanbul Sabahattin Zaim University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 13, 2022