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The effect of mirror therapy on the phantom limb pain and sexual satisfaction in men with lower limb amputation

Protocol summary

Study aim
The effect of mirror therapy on phantom limb pain and sexual satisfaction in men with lower limb amputation referred to Government clinics in Rasht
Design
A clinical trial with the control group, parallel-group, randomized groups, without blinding, sample size 50 people (intervention of 25, control of 25)
Settings and conduct
This study is a randomized clinical trial. The study population is men with lower limb amputation referred to government clinics in Rasht. The sample size is estimated at 50 people. After determining the people who are eligible to enter the study, the samples are randomly divided into two groups, intervention, and control, based on Random allocation software.
Participants/Inclusion and exclusion criteria
Inclusion criteria: One-sided amputation of the lower limb; Pain in the phantom limb with the severity of at least 20; Married and monogamous men. Exclusion criteria: History of sexual dysfunction before amputation; Movement disorders or barriers (cast, splint, etc.) in the healthy lower limb.
Intervention groups
In the intervention group (Mirror therapy), subjects will be in front of a mirror with dimensions of 80 x 30 cm. So that the amputated limb is behind the mirror and the healthy lower limb is in front of the mirror and the person can see a clear image of the reflection of the healthy limb in the mirror. Each session of mirror therapy will be 15 minutes and 5 sessions per week for 28 days (in total, 20 sessions of 15 minutes). In each session of mirror therapy, 5 minutes will be devoted to opening and closing the healthy foot in front of the mirror, 5 minutes to rotating the ankle inward, and 5 minutes to the rotation of the ankle outward. Control group: No specific intervention by the researcher will be performed in this group.
Main outcome variables
Pain score in a Pain Visual Analogue Scale; Scores obtained in the Sexual Satisfaction Questionnaire

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190805044438N3
Registration date: 2021-07-30, 1400/05/08
Registration timing: prospective

Last update: 2021-07-30, 1400/05/08
Update count: 0
Registration date
2021-07-30, 1400/05/08
Registrant information
Name
Roya Mansour-ghanaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 4256 5058
Email address
r_ghanaei@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-23, 1400/06/01
Expected recruitment end date
2021-12-22, 1400/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of mirror therapy on the phantom limb pain and sexual satisfaction in men with lower limb amputation
Public title
The effect of mirror therapy on the phantom limb pain and sexual satisfaction in men with lower limb amputation
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Married and monogamous men Age 18 to 60 years old One-sided amputation of the lower limb at two partial levels (from toes to ankle) or extensive levels (above ankle to thigh) Pain in the phantom limb with a severity of at least 20 Sufficient cognitive ability according to AMT tool Informed consent to participate in the study
Exclusion criteria:
History of sexual dysfunction before amputation Sexual disorder drugs consumption during the study New analgesics consumption during the study Thyroid disorders Malignant diseases Visual disturbances Severe hearing loss Movement disorders or barriers (cast, splint, etc.) in the healthy lower limb
Age
From 18 years old to 60 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals are entered into the study according to the study criteria. Individuals are simple randomly assigned to the intervention and control groups with the Random Allocation software. The unit of randomization is individual and study without blinding and parallel.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Deputy of university Research and Technology of the University, Old Bldg (building) School of Health, in front of 17 Shahrivar Hospital, Shahid Siadati Ave, Namjoo St, Rasht
City
Rasht
Province
Guilan
Postal code
4477163485
Approval date
2021-07-14, 1400/04/23
Ethics committee reference number
IR.GUMS.REC.1400.174

Health conditions studied

1

Description of health condition studied
Amputation
ICD-10 code
Y83.5
ICD-10 code description
Amputation of limb(s)

Primary outcomes

1

Description
Pain score in a Pain Visual Analogue Scale
Timepoint
Before intervention and 7, 14, 21 and 28 days after the start of mirror therapy
Method of measurement
Pain Visual Analogue Scale

2

Description
Scores obtained in the Sexual Satisfaction Questionnaire
Timepoint
Before intervention and 28 days after the start of mirror therapy
Method of measurement
Larson Sexual Satisfaction Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: At the beginning of the study, before starting mirror therapy, the degree of phantom limb pain and sexual satisfaction in individuals will be determined before the session begins. In this method, subjects will be in front of a mirror with dimensions of 30x80 cm, in such a way that the amputated limb is behind the mirror and the healthy limb is in front of the mirror so that the subject can see a clear image of the movements of the healthy limb in the mirror. Each mirror therapy session will be 15 minutes. Subjects will have 5 sessions per week for 28 days. In each session of mirror therapy, 5 minutes will be devoted to opening and closing the healthy foot in front of the mirror, 5 minutes to rotating the ankle inward, and 5 minutes to rotation of the ankle outward. All participants will complete a total of twenty 15-minute sessions. 7, 14 and 21 days after the intervention, the degree of phantom limb pain will be measured by a VAS instrument and on the 28th day after the end of the intervention, sexual satisfaction will also be assessed in addition to the phantom limb pain. After the first session, when the researchers ensured that the patients have learned correctly how to perform mirror therapy, they provided written instructions to the patients so that they could continue the mirror therapy process at home. Every week 2 phone calls were made to review the process, to encourage people to perform the process regularly, and to answer participants' questions.
Category
Rehabilitation

2

Description
Control group: No specific intervention by the researcher will be performed on patients in this group.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Government Clinics of Guilan University of Medical Sciences in Rasht (Besat, Razi, Poursina)
Full name of responsible person
Roya Mansour-ghanaei
Street address
Martyr Yaghoub Sheikhi St., Leyla Kooh, Langeroud, Rasht, Iran
City
Langeroud
Province
Guilan
Postal code
4477163485
Phone
+98 13 4256 5058
Email
r_ghanaei@gums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr. Mohamadreza Naghipour
Street address
Deputy of university Research and Technology of the University, Old Bldg (building) School of Health, in front of 17 Shahrivar Hospital, Shahid Siadati Ave, Namjoo St, Rasht
City
Rasht
Province
Guilan
Postal code
4477163485
Phone
+98 13 3333 5821
Fax
+98 13 3333 6395
Email
r_ghanaei@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Roya Mansour-ghanaei
Position
Assistant Professor, Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Health Sciences
Street address
Martyr Yaghoub Sheikhi St., Leyla Kooh, Langeroud, Rasht, Iran
City
Langeroud
Province
Guilan
Postal code
4477163485
Phone
+98 13 4256 5058
Email
r_ghanaei@gums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Roya Mansour-ghanaei
Position
Assistant Professor, Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Health Sciences
Street address
Martyr Yaghoub Sheikhi St., Leyla Kooh, Langeroud, Rasht, Iran
City
Langeroud
Province
Guilan
Postal code
4477163485
Phone
+98 13 4256 5058
Fax
Email
r_ghanaei@gums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Roya Mansour-ghanaei
Position
Assistant Professor, Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Health Sciences
Street address
Martyr Yaghoub Sheikhi St., Leyla Kooh, Langeroud, Rasht, Iran
City
Langeroud
Province
Guilan
Postal code
4477163485
Phone
+98 13 4256 5058
Email
r_ghanaei@gums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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