Multiple Sclerosis Clinical Trial
Official title:
Fatigue and Sleep Quality in Multiple Sclerosis Patients: Does Reiki Application Affect?
NCT number | NCT05456464 |
Other study ID # | 6812 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 1, 2022 |
Est. completion date | September 30, 2022 |
Verified date | August 2023 |
Source | Istanbul Sabahattin Zaim University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study was planned to examine the effect of reiki application on fatigue and sleep quality in patients with multiple sclerosis.
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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Istanbul Sabahattin Zaim University, Faculty of Health Sciences | Istanbul | Güneydogu Anadolu Bölgesi |
Lead Sponsor | Collaborator |
---|---|
Istanbul Sabahattin Zaim University |
Turkey,
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
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) |
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