Fatigue and Sleep Quality in Multiple Sclerosis Patients

NCT05456464 | Completed

• 1 other identifier: 6812
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Multiple Sclerosis

Keywords

Reiki; Fatigue; Sleep quality; Nursing

Outcome Measures

Primary Outcomes (4)

• 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)

Study Arms (2)

Reiki

EXPERIMENTAL

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

Control group

NO INTERVENTION

Routine maintenance will be applied

Interventions

Reiki OTHER

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.

Reiki

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Istanbul Sabahattin Zaim University: lead

Study Sites (1)

Istanbul Sabahattin Zaim University, Faculty of Health Sciences

Istanbul, Güneydoğu Anadolu Bölgesi, 340340, Turkey (Türkiye)

Location

Related 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.

  PMID: 26163604 RESULT

MeSH Terms

Conditions

Multiple Sclerosis; Fatigue; Sleep Initiation and Maintenance Disorders

Interventions

Therapeutic Touch

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies

Study Officials

• Zülfünaz Özer, PhD

  Istanbul Sabahattin Zaim University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Reiki and control group
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Model Details: The research will be conducted as a randomized, experimental study with a pretest-posttest control group.

Study Record Dates

• First Submitted: July 5, 2022
• First Posted: July 13, 2022
• Study Start: June 1, 2022
• Primary Completion: August 8, 2022
• Study Completion: September 30, 2022
• Last Updated: August 31, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)