NCT05684445

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 20, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 13, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2023

Completed
Last Updated

January 31, 2024

Status Verified

January 1, 2024

Enrollment Period

7 months

First QC Date

January 5, 2023

Last Update Submit

January 30, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    10 days

Study Arms (1)

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.

Other: Distant reiki group

Interventions

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.

Distant reiki group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.)

You may not qualify if:

  • individuals who have done reiki therapy before

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cemile KÜTMEÇ YILMAZ

Merkez, Aksaray, 68100, Turkey (Türkiye)

Location

Aksaray University Health Science Faculty

Aksaray, 68100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Phantom Limb

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPain, PostoperativePostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsPain

Study Officials

  • CEMİLE KÜTMEÇ YILMAZ, Dr.

    Aksaray University, Faculty of Health Science, Nursing Department, Turkey

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: This study is an experimental one-group pre-test-post-test design.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 5, 2023

First Posted

January 13, 2023

Study Start

October 20, 2022

Primary Completion

May 20, 2023

Study Completion

September 20, 2023

Last Updated

January 31, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations