The Effect of Distant Reiki on Pain and Holistic Well-being
Primary Purpose
Phantom Limb Pain
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Distant reiki group
Sponsored by
About this trial
This is an interventional supportive care trial for Phantom Limb Pain
Eligibility Criteria
Inclusion Criteria: Above 18 years old, İndividuals with limb loss and phantom pain No communication problem, Have the physical and cognitive ability to answer the data collection forms, Individuals who have not received body-mind therapy (yoga, reiki, meditation, etc.) Exclusion Criteria: individuals who have done reiki therapy before
Sites / Locations
- Cemile KÜTMEÇ YILMAZ
- Aksaray University Health Science FacultyRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Distant reiki group
Arm Description
According to Classical Usui Reiki, Reiki II. Remote Reiki will be practiced every day for 10 days by researchers who have completed the Phase 1 training. The time of remote reiki application will be planned by talking with the patient.
Outcomes
Primary Outcome Measures
Visual pain Scale
The pain scores of the individuals will be measured after the pre-test and the 10th days using the visual pain scale. Pain score min 1 - max 10. An increase in the score indicates an increase in pain intensity.
Holistic Well-being Scale
Holistic Well-being Scale scores of the individuals will be measured after the pre-test and the 10th days using the Holistic Well-being Scale. The instrument consists of 26 items rated on a 10-point Likert-type scale (1 = strongly disagree to 10 = strongly agree). The scale has no cut-off point.
Secondary Outcome Measures
Full Information
NCT ID
NCT05684445
First Posted
January 5, 2023
Last Updated
January 12, 2023
Sponsor
Aksaray University Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05684445
Brief Title
The Effect of Distant Reiki on Pain and Holistic Well-being
Official Title
The Effect of Distant Reiki on Pain and Holistic Well-being of Individuals With Phantom Pain After Amputation
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 20, 2022 (Actual)
Primary Completion Date
April 20, 2023 (Anticipated)
Study Completion Date
June 20, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aksaray University Training and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Phantom limb pain is a condition characterized by painful sensations in the missing part of the amputated limb, which reduces the quality of life of the individual. It has been reported that approximately 85% of patients undergoing amputation experience phantom limb pain, and chronic pain is the most common symptom in individuals who have undergone limb amputation. These problems negatively affect individuals physically, mentally and socially and lead to deterioration of holistic well-being. This study will be examined the effect of distant reiki on pain and holistic well-being of ındividuals with phantom pain after amputation.
Detailed Description
Phantom limb pain is a condition characterized by painful sensations in the missing part of the amputated limb, which reduces the quality of life of the individual. It has been reported that approximately 85% of patients undergoing amputation experience phantom limb pain, and chronic pain is the most common symptom in individuals who have undergone limb amputation. These problems negatively affect individuals physically, mentally and socially and lead to deterioration of holistic well-being.
Reiki is one of the holistic health practices that is effective in maintaining the balance between body, mind and spirit, which forms the basis of holistic well-being. Reiki, known as an energy-based therapy, helps to rebalance the natural energy flow circulating in the body and to increase the body's self-healing ability, and it prevents or repairs physical, emotional and mental imbalances by regaining the energy we lost in daily life. The purpose of Reiki practice is to promote health and well-being by helping to relax and reduce stress.There is no study in the literature examining the effect of reiki application on phantom pain and holistic well-being.This study was planned to examine the effect of remote reiki applied to individuals with post-amputation phantom pain on pain and holistic well-being.It is thought that it will contribute to the literature in terms of being the first research to be done on this subject.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Phantom Limb Pain
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This study is an experimental one-group pre-test-post-test design.
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Distant reiki group
Arm Type
Experimental
Arm Description
According to Classical Usui Reiki, Reiki II. Remote Reiki will be practiced every day for 10 days by researchers who have completed the Phase 1 training. The time of remote reiki application will be planned by talking with the patient.
Intervention Type
Other
Intervention Name(s)
Distant reiki group
Intervention Description
According to Classical Usui Reiki, Reiki II. Remote Reiki will be practiced every day for 10 days by researchers who have completed the Phase 1 training. The time of remote reiki application will be planned by talking with the patient.
Primary Outcome Measure Information:
Title
Visual pain Scale
Description
The pain scores of the individuals will be measured after the pre-test and the 10th days using the visual pain scale. Pain score min 1 - max 10. An increase in the score indicates an increase in pain intensity.
Time Frame
10 days
Title
Holistic Well-being Scale
Description
Holistic Well-being Scale scores of the individuals will be measured after the pre-test and the 10th days using the Holistic Well-being Scale. The instrument consists of 26 items rated on a 10-point Likert-type scale (1 = strongly disagree to 10 = strongly agree). The scale has no cut-off point.
Time Frame
10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Above 18 years old,
İndividuals with limb loss and phantom pain
No communication problem,
Have the physical and cognitive ability to answer the data collection forms,
Individuals who have not received body-mind therapy (yoga, reiki, meditation, etc.)
Exclusion Criteria:
individuals who have done reiki therapy before
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
cemile KÜTMEÇ YILMAZ, Dr.
Phone
+9003822882784
Email
cemilekutmec@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmet KARAKOYUN, Dr.
Phone
0382 288 29 00
Email
furkankk42@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CEMİLE KÜTMEÇ YILMAZ, Dr.
Organizational Affiliation
Aksaray University, Faculty of Health Science, Nursing Department, Turkey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cemile KÜTMEÇ YILMAZ
City
Merkez
State/Province
Aksaray
ZIP/Postal Code
68100
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cemile K YILMAZ
Phone
3822882771
Email
cemilekutmec@yahoo.com
First Name & Middle Initial & Last Name & Degree
Cemile K YILMAZ
Phone
03822882771
Email
cemilekutmec@yahoo.com
Facility Name
Aksaray University Health Science Faculty
City
Aksaray
ZIP/Postal Code
68100
Country
Turkey
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
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The Effect of Distant Reiki on Pain and Holistic Well-being
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