Phantom Limb PainNCT05684445
The Effect of Distant Reiki on Pain and Holistic Well-being
A study testing Distant reiki group in people with Phantom Limb Pain, run by Aksaray University Training and Research Hospital at 2 sites in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Phantom Limb Pain
- What is being tested?
- Distant reiki group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 20 Oct 2022to 20 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.)
Who cannot join
- individuals who have done reiki therapy before
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Aksaray University Health Science Faculty
Aksaray, 68100
Cemile KÜTMEÇ YILMAZ
Merkez, Aksaray, 68100
About this study
Official title: The Effect of Distant Reiki on Pain and Holistic Well-being of Individuals With Phantom Pain After Amputation
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.
Read the 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.
- Conditions
- Phantom Limb Pain
- Being tested
- Distant reiki group
- Medical subject headings
- Phantom Limb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distant reiki groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Distant reiki group | Experimental | 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. Receives: Other: Distant reiki group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 days
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.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start20 Oct 2022
- Primary completion20 May 2023
- Study completion20 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Phantom Limb PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study is an experimental one-group pre-test-post-test design.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aksaray University Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cemile KÜTMEÇ YILMAZ, Aksaray University Training and Research Hospital
- Investigators
- CEMİLE KÜTMEÇ YILMAZ, Dr., Principal investigator, Aksaray University, Faculty of Health Science, Nursing Department, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05684445
- Sponsor's protocol ID
- 2022/14-07
- Status last verified
- Jan 2024
- First submitted
- 5 Jan 2023
- Last updated
- 31 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Distant Reiki on Pain and Holistic Well-being of Individuals With Phantom Pain After Amputation
- ClinicalTrials.gov ID
- NCT05684445
- Acronym / sponsor ID
- 2022/14-07
- Conditions
- Phantom Limb Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Aksaray University Training and Research HospitalUniversity, hospital or other
- Study start
- 20 Oct 2022 (actual)
- Primary completion
- 20 May 2023 (actual)
- Study completion
- 20 Sep 2023 (actual)
- First posted
- 13 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study is an experimental one-group pre-test-post-test design.
| Arm | Type | Receives |
|---|---|---|
| Distant reiki group | Experimental | Other: Distant reiki groupAccording 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.)
Key exclusion criteria (1 listed)
- individuals who have done reiki therapy before
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Distant reiki groupAccording 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. | Other | Distant reiki group |
Primary outcome
Visual pain Scale
Time frame: 10 days
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
Time frame: 10 days
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Phantom Limb Pain
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Uses of Phantom Sensations Induced by Global and Local Modifications of the Prosthetic Socket as Somatosensory Feedback During Walking in Lower Limb Amputees
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TENS for Restoring Somatotopic Sensory Feedback in Lower Limb Amputees and Improving Phantom Limb Perception
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
CEMİLE KÜTMEÇ YILMAZ, Dr. principal investigator
Aksaray University, Faculty of Health Science, Nursing Department, Turkey
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Distant reiki group in people with Phantom Limb Pain, run by Aksaray University Training and Research Hospital at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual pain Scale (time frame: 10 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2024.