Fatigue and Sleep Quality in Multiple Sclerosis Patients

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Reiki

About this trial

This is an interventional supportive care trial for Multiple Sclerosis focused on measuring Reiki, Fatigue, Sleep quality, Nursing

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Istanbul Sabahattin Zaim University, Faculty of Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Reiki

Control group

Arm Description

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.

Routine maintenance will be applied

Outcomes

Primary Outcome Measures

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.

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.

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"

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"

Secondary Outcome Measures

Full Information

NCT ID

NCT05456464

First Posted

July 5, 2022

Last Updated

August 30, 2023

Sponsor

Istanbul Sabahattin Zaim University

1. Study Identification

Unique Protocol Identification Number

NCT05456464

Brief Title

Fatigue and Sleep Quality in Multiple Sclerosis Patients

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

June 1, 2022 (Actual)

Primary Completion Date

August 8, 2022 (Actual)

Study Completion Date

September 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Istanbul Sabahattin Zaim University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. 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.

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis

Keywords

Reiki, Fatigue, Sleep quality, Nursing

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

Participant

Masking Description

Reiki and control group

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Reiki

Arm Type

Experimental

Arm Description

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.

Arm Title

Control group

Arm Type

No Intervention

Arm Description

Routine maintenance will be applied

Intervention Type

Other

Intervention Name(s)

Reiki

Intervention Description

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.

Primary Outcome Measure Information:

Title

The Piper Fatigue Scale

Description

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.

Time Frame

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)

Title

The Piper Fatigue Scale

Description

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.

Time Frame

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)

Title

Pittsburgh Sleep Quality Index (PSQI)

Description

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"

Time Frame

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)

Title

Pittsburgh Sleep Quality Index (PSQI)

Description

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"

Time Frame

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)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zülfünaz Özer, PhD

Organizational Affiliation

Istanbul Sabahattin Zaim University

Official's Role

Study Director

Facility Information:

Facility Name

Istanbul Sabahattin Zaim University, Faculty of Health Sciences

City

Istanbul

State/Province

Güneydoğu Anadolu Bölgesi

ZIP/Postal Code

340340

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

No

Citations:

PubMed Identifier

26163604

Citation

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.

Results Reference

result

Multiple Sclerosis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial