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IRCT20231103059942N1 IRCT 2024-11-06 Research and Technology Deputy Investigating the impact of guided imagery on restless leg syndrome Investigating the impact of guided imagery on severity of restless leg syndrome in the elderly undergoing hemodialysis: A randomized controlled trial 2024-02-20 anticipated 72 Complete https://irct.ir/trial/74437 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done by premutation block method with block size 4 and based on the generated sequence list, people will be assigned to 2 intervention and control groups, Blinding description: Using random sequence sealed opaque envelopes (SNOSE). After determining the random sequence using the block method, based on the sample size of the research, a number of envelopes with aluminum wrappers (in order to the contents of the envelopes unclear) are prepared and each of the generated random sequences is recorded on a card and the cards inside the letter envelopes are placed in order. In order to maintain a random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed in a box respectively. At the time of registration of the participants, based on the order of entry of eligible participants into the study, one of the envelopes will be opened and the assigned group of that participant will be revealed. N/A Restless Leg Syndrome. Intervention 1: "Intervention group" : First, elderly patients who meet the study entry criteria will be selected and examined after obtaining informed consent. Brief Cognitive Status Questionnaire (AMT), Demographic Information Questionnaire and Restless Leg Syndrome Severity Assessment Tool (RLSSG) will be completed by the patients and guided visualization by audio tapes will be prepared and presented to the elderly through headphones. The content of the CD used in the guided visualization will include the visualization of a combination of soothing nature scenes, comforting psychological sentences, and the use of translation of some verses of the Holy Quran to engage the minds of the participants through both traditional and modern methods."Intervention group": for four weeks and four sessions per week (two days a week, one session in the morning at the dialysis center and one session at night at home) under guided visualization training using an audio training CD prepared by the psychologist present in the study. They will sit and listen to it. In order to control disturbing factors such as noise in the ward, the intervention will be carried out in the morning shift in a quiet environment and every day with the presence of the researcher, and for the night shift it will be done at the patient's home. To ensure that the patient listens to the audio tape at home, the patient will be contacted by phone. After four weeks, both control. Intervention 2: "Control group" : First, elderly patients who meet the study entry criteria will be selected and examined after obtaining informed consent. Brief Cognitive Status Questionnaire (AMT), Demographic Information Questionnaire and Restless Leg Syndrome Severity Assessment Tool (RLSSG) will be completed by the patients. They will receive only routine care during the study period, at the end of the study they will receive a guided visualization CD to use if they wish. 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 There is no further information
public Parand Pourghane
Zeynab School of Nursing and Midwifery, Yaghoub Sheikhi Ave, Leila Kooh Road, Langroud
Langroud Iran (Islamic Republic of) 4477166595 +98 13 4256 5052 Pourghanep@gmail.com Rasht University of Medical Sciences scientific Parand Pourghane
Zeynab School of Nursing and Midwifery, Yaghoub Sheikhi Ave, Leila kooh Road, Langroud
Langroud Iran (Islamic Republic of) 4477166595 +98 13 4256 5052 pourghanep@gmail.com Rasht University of Medical Sciences Iran (Islamic Republic of) 60 years and older Ability to understand and speak Persian Informed consent to take part in the study A history of hemodialysis at least for 6 months Being developed to restless leg syndrome Appropriate mental and cognitive ability Resistance to routine treatments 60 years no limit Both Not using other relaxation methods such as yoga Absence of known mental illness such as schizophrenia Absence of hearing disorders Not using drugs affecting the patient's mental state Treatment - Other Treatment - Other "Intervention group" : First, elderly patients who meet the study entry criteria will be selected and examined after obtaining informed consent. Brief Cognitive Status Questionnaire (AMT), Demographic Information Questionnaire and Restless Leg Syndrome Severity Assessment Tool (RLSSG) will be completed by the patients and guided visualization by audio tapes will be prepared and presented to the elderly through headphones. The content of the CD used in the guided visualization will include the visualization of a combination of soothing nature scenes, comforting psychological sentences, and the use of translation of some verses of the Holy Quran to engage the minds of the participants through both traditional and modern methods."Intervention group": for four weeks and four sessions per week (two days a week, one session in the morning at the dialysis center and one session at night at home) under guided visualization training using an audio training CD prepared by the psychologist present in the study. They will sit and listen to it. In order to control disturbing factors such as noise in the ward, the intervention will be carried out in the morning shift in a quiet environment and every day with the presence of the researcher, and for the night shift it will be done at the patient's home. To ensure that the patient listens to the audio tape at home, the patient will be contacted by phone. After four weeks, both control. "Control group" : First, elderly patients who meet the study entry criteria will be selected and examined after obtaining informed consent. Brief Cognitive Status Questionnaire (AMT), Demographic Information Questionnaire and Restless Leg Syndrome Severity Assessment Tool (RLSSG) will be completed by the patients. They will receive only routine care during the study period, at the end of the study they will receive a guided visualization CD to use if they wish. Severity of restless leg syndrome. Timepoint: At the begining of the study and also after implementation of guided imagery. Method of measurement: Through a dedicated questionnaire. Research and Technology Deputy Approved 2023-09-13 Ethics comittee of Guilan University of Medical Sciences Namjoo Ave, Rasht Rasht Guilan Iran (Islamic Republic of)