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The Effect of Reiki Application on Pain, Fatigue and Sleep Quality in Elderly Persons Staying in Nursing Homes

Primary Purpose

Pain, Tiredness, Sleep Quality

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
pain
Sponsored by
Ataturk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: • Being a nursing home resident and being 50 years or older, Not having a communication problem, Not having been diagnosed with bipolar disorder, schizophrenia or other mental illness, Not taking antidepressant treatment, Having chronic pain (arthralgia, back pain, musculoskeletal pain - at least once a day), Not using a pain reliever all the time, Willingness to participate in a four-week reiki program, Not having received body-mind therapy (yoga, reiki, massage, meditation) in the last six months. Having a scale score of >5 on the Piper Fatigue Scale A score of >5 on the Pittsburgh Sleep Quality Scale A scale score of >5 on the Visual Analog Scale Exclusion Criteria: Needing antidepressant treatment, Not getting bored with work and not wanting to answer questions. Exclusion Criteria: -

Sites / Locations

  • Gülcan B TuranRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental:

control

Arm Description

reiki will be aplicated

Routine maintenance will be applied.

Outcomes

Primary Outcome Measures

Pittsburgh Sleep Quality Index (PUKI);
The scale is a safe and consistent questionnaire that evaluates the amount of sleep, sleep quality, presence and severity of sleep disorders in individuals in the last month.There are seven components in PUKI. These components are subjective sleep quality (component 1), sleep latency (component 2), sleep duration (component 3), habitual sleep efficiency (component 4), sleep disturbance (component 5), sleep medication use (component 6) and daytime dysfunction. (component 7). The evaluation score of each item is between 0-3. The total score obtained varies between 0-21. The higher the score, the worse the sleep quality. A score greater than five indicates poor sleep quality.
Piper Fatigue Scale
The scale evaluates the individual's subjective perception of fatigue in four sub-dimensions. These; behavior/violence sub-dimension evaluating the effect and severity of fatigue on activities of daily living (ADLs (6 items; 2-7); affect sub-dimension, which includes the emotional meaning attributed to fatigue (5 items; 8-12); it is the sensory sub-dimension (5 items; 13-17) that reflects the mental, physical and emotional symptoms of fatigue, and the cognitive/spiritual sub-dimension that reflects the effect of fatigue on cognitive functions and mental state (6 items; 18-23). As a result of the average score; 0 points are interpreted as no fatigue, 1-3 points as mild fatigue, 4-6 points as moderate fatigue, 7-10 points as severe fatigue. High scores obtained from the scale mean that the perceived fatigue level is high.
Visual Analog Scale (VAS) Evaluation
The Visual Analog Scale (VAS) is used to convert some values that cannot be measured numerically. Two end definitions of the parameter to be evaluated are written at the two ends of a 100 mm line, and the patient is asked to indicate where on this line their situation is appropriate by drawing a line or by placing a dot or pointing. For example, for pain, I have no pain at one end and very severe pain at the other end and the patient marks his/her current state on this line. The length of the distance from the point where there is no pain to the point marked by the patient indicates the patient's pain.

Secondary Outcome Measures

Full Information

First Posted
January 28, 2023
Last Updated
January 28, 2023
Sponsor
Ataturk University
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1. Study Identification

Unique Protocol Identification Number
NCT05716373
Brief Title
The Effect of Reiki Application on Pain, Fatigue and Sleep Quality in Elderly Persons Staying in Nursing Homes
Official Title
The Effect of Reiki Application on Pain, Fatigue and Sleep Quality in Elderly Persons Staying in Nursing Homes
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
January 6, 2023 (Actual)
Study Completion Date
April 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ataturk University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A person's life is a stage that passes in the time interval that ends with his birth when he opens his eyes to the world and his death when he closes his eyes to the world. Old age is a forced end for all people. Sleep is one of the most important and basic human needs. It prepares the individual for a new day by resting the body, strengthening and regulating the cerebral functions and repairing the brain. While a change in sleep pattern and quality affects a person's daily life activities, long-term persistence of this change may lead to deterioration of body and mental health.During Reiki practices, the hands are held in each position for 3-5 minutes by touching the head, neck, chest, abdominal cavity and groin. In problem areas, this time can be extended to 10-20 minutes. The duration of treatment lasts an average of 30-90 minutes. During the application, the person is in a lying or lying position and does not need to take off his clothes.
Detailed Description
In the elderly, the pathology of fatigue has not yet been fully elucidated. Natural changes and the disadvantages of age can be the cause of fatigue. Decrease in muscle strength, sarcopenia, pain, inactivity, changes in body composition due to malnutrition, decrease in physical fitness, insufficient energy systems, cardiovascular and respiratory problems, medications used can cause fatigue in the elderly. It has been shown that 27-50% of the elderly suffer from moderate to severe fatigue. Increasing the severity of fatigue reduces the daily activity performance of the elderly (6). Today, in many areas, in addition to medical treatment to reduce the symptoms of chronic diseases, alternative and complementary medicine are also used. Reiki, which constitutes our research subject; one of the energy approaches, in Japan at the end of the 19th century, Dr. It is a complementary medicine application discovered by Usui in Sanskrit inscriptions, which has been shown to be effective on pain, depression, insomnia and fatigue symptoms. Reiki is generally safe and no serious side effects have been reported. Reiki practice in the last 10 years; it increases among physicians, nurses and other health workers.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Tiredness, Sleep Quality

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
reiki
Masking
Participant
Masking Description
Single (Participant) pain,tiredness,sleep quality
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental:
Arm Type
Experimental
Arm Description
reiki will be aplicated
Arm Title
control
Arm Type
No Intervention
Arm Description
Routine maintenance will be applied.
Intervention Type
Behavioral
Intervention Name(s)
pain
Other Intervention Name(s)
tiredness, sleep quality
Intervention Description
reiki
Primary Outcome Measure Information:
Title
Pittsburgh Sleep Quality Index (PUKI);
Description
The scale is a safe and consistent questionnaire that evaluates the amount of sleep, sleep quality, presence and severity of sleep disorders in individuals in the last month.There are seven components in PUKI. These components are subjective sleep quality (component 1), sleep latency (component 2), sleep duration (component 3), habitual sleep efficiency (component 4), sleep disturbance (component 5), sleep medication use (component 6) and daytime dysfunction. (component 7). The evaluation score of each item is between 0-3. The total score obtained varies between 0-21. The higher the score, the worse the sleep quality. A score greater than five indicates poor sleep quality.
Time Frame
1 hours later
Title
Piper Fatigue Scale
Description
The scale evaluates the individual's subjective perception of fatigue in four sub-dimensions. These; behavior/violence sub-dimension evaluating the effect and severity of fatigue on activities of daily living (ADLs (6 items; 2-7); affect sub-dimension, which includes the emotional meaning attributed to fatigue (5 items; 8-12); it is the sensory sub-dimension (5 items; 13-17) that reflects the mental, physical and emotional symptoms of fatigue, and the cognitive/spiritual sub-dimension that reflects the effect of fatigue on cognitive functions and mental state (6 items; 18-23). As a result of the average score; 0 points are interpreted as no fatigue, 1-3 points as mild fatigue, 4-6 points as moderate fatigue, 7-10 points as severe fatigue. High scores obtained from the scale mean that the perceived fatigue level is high.
Time Frame
1 hours later
Title
Visual Analog Scale (VAS) Evaluation
Description
The Visual Analog Scale (VAS) is used to convert some values that cannot be measured numerically. Two end definitions of the parameter to be evaluated are written at the two ends of a 100 mm line, and the patient is asked to indicate where on this line their situation is appropriate by drawing a line or by placing a dot or pointing. For example, for pain, I have no pain at one end and very severe pain at the other end and the patient marks his/her current state on this line. The length of the distance from the point where there is no pain to the point marked by the patient indicates the patient's pain.
Time Frame
1 hours later

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: • Being a nursing home resident and being 50 years or older, Not having a communication problem, Not having been diagnosed with bipolar disorder, schizophrenia or other mental illness, Not taking antidepressant treatment, Having chronic pain (arthralgia, back pain, musculoskeletal pain - at least once a day), Not using a pain reliever all the time, Willingness to participate in a four-week reiki program, Not having received body-mind therapy (yoga, reiki, massage, meditation) in the last six months. Having a scale score of >5 on the Piper Fatigue Scale A score of >5 on the Pittsburgh Sleep Quality Scale A scale score of >5 on the Visual Analog Scale Exclusion Criteria: Needing antidepressant treatment, Not getting bored with work and not wanting to answer questions. Exclusion Criteria: -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gülcan B.TURAN, PHD
Phone
05065576086
Email
glcnbah@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Esra Tosun, STD
Phone
05347908640
Facility Information:
Facility Name
Gülcan B Turan
City
Elazığ
State/Province
Merkez
ZIP/Postal Code
23000
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Esra

12. IPD Sharing Statement

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The Effect of Reiki Application on Pain, Fatigue and Sleep Quality in Elderly Persons Staying in Nursing Homes

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