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IRCT20190805044438N3 IRCT 2021-07-30 Rasht University of Medical Sciences The effect of mirror therapy on the phantom limb pain and sexual satisfaction in men with lower limb amputation The effect of mirror therapy on the phantom limb pain and sexual satisfaction in men with lower limb amputation 2021-08-23 anticipated 50 Complete https://irct.ir/trial/49237 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, 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. N/A Amputation. Intervention 1: 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. Intervention 2: Control group: No specific intervention by the researcher will be performed on patients in this group. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is We have not decided yet
public Roya Mansour-ghanaei
Martyr Yaghoub Sheikhi St., Leyla Kooh, Langeroud, Rasht, Iran
Langeroud Iran (Islamic Republic of) 4477163485 +98 13 4256 5058 r_ghanaei@gums.ac.ir Rasht University of Medical Sciences scientific Roya Mansour-ghanaei
Martyr Yaghoub Sheikhi St., Leyla Kooh, Langeroud, Rasht, Iran
Langeroud Iran (Islamic Republic of) 4477163485 +98 13 4256 5058 r_ghanaei@gums.ac.ir Rasht University of Medical Sciences Iran (Islamic Republic of) 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 18 years 60 years Male 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 Y83.5 Amputation of limb(s) Rehabilitation N/A 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. Control group: No specific intervention by the researcher will be performed on patients in this group. 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. 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. Rasht University of Medical Sciences Approved 2021-07-14 Ethics committee of Guilan University of Medical Sciences 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 Rasht Guilan Iran (Islamic Republic of)