Protocol summary

Study aim
Determining the effect of guided visualization on restless leg syndrome in the elderly undergoing hemodialysis in East Gilan
Design
The study group includes 72 elderly hemodialysis suffers with restless leg syndrome who will be examined in two intervention and control groups(36 people each). Randomization will be done by permutation block method with block 4. By entering the Randomization.com and entering the size and number of blocks, a random allocation sequence will be generated.
Settings and conduct
72 older people (36 in each group) in hemodialysis centers of East Guilan hospitals will be participated. Intervention group will undergo guided imagery training using training CD for 4 weeks and 4 sessions per week. After four weeks, the restless leg syndrome questionnaire will be administered again. Double blinding will be done which will include participants and analysts to prevent any deviation from the true results.
Participants/Inclusion and exclusion criteria
Inclusion criteria:60 years old or older, ability to understand and speak Persian, informed consent , having restless leg syndrome with mild-moderate and severe severity, adequate mental and cognitive ability, lack of Existence of a known mental illness, a history of at least six months of hemodialysis, no obvious hearing disorders, no use of drugs affecting the patient's mental state, no use of other methods sedation and patients resistant to routine treatments during the study. ٍExclusion criteria: Lacking of inclusion criteria
Intervention groups
"Intervention group": four weeks and four times per week will be guided visualization training using audio training CD. After four weeks and will complete the Restless Leg Syndrome questionnaire again. "Control group": will continue their routine treatments and guided visualization will not be performed on the their
Main outcome variables
Severity of restless leg syndrome

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231103059942N1
Registration date: 2024-11-06, 1403/08/16
Registration timing: retrospective

Last update: 2024-11-06, 1403/08/16
Update count: 0
Registration date
2024-11-06, 1403/08/16
Registrant information
Name
Ali Nouri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3344 4322
Email address
ali.nouri21@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-20, 1402/12/01
Expected recruitment end date
2024-05-21, 1403/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the impact of guided imagery on severity of restless leg syndrome in the elderly undergoing hemodialysis: A randomized controlled trial
Public title
Investigating the impact of guided imagery on restless leg syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 72
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics comittee of Guilan University of Medical Sciences
Street address
Namjoo Ave, Rasht
City
Rasht
Province
Guilan
Postal code
4477166595
Approval date
2023-09-13, 1402/06/22
Ethics committee reference number
IR.GUMS.REC.1402.327

Health conditions studied

1

Description of health condition studied
Restless Leg Syndrome
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
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

Secondary outcomes

empty

Intervention groups

1

Description
"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.
Category
Treatment - Other

2

Description
"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.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Amini Hospital
Full name of responsible person
Parand Pourghane
Street address
Imam Khomeini Ave, Langroud
City
Langroud
Province
Guilan
Postal code
4477166595
Phone
+98 13 4256 5059
Email
ali.nouri21@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research and Technology Deputy
Full name of responsible person
Mohammad Esmaeilpour-Bandboni
Street address
Zeynab School of Nursing and Midwifery, Yaghoub Sheikhi Ave, Leila Kooh Road, Langroud.
City
Langroud
Province
Guilan
Postal code
4477166595
Phone
+98 13 4256 5052
Email
esmaeilmmm@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research and Technology Deputy
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
Parand Pourghane
Position
َAssociate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Zeynab School of Nursing and Midwifery, Yaghoub Sheikhi Ave, Leila Kooh Road, Langroud
City
Langroud
Province
Guilan
Postal code
4477166595
Phone
+98 13 4256 5052
Email
Pourghanep@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Parand Pourghane
Position
َAssociate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Zeynab School of Nursing and Midwifery, Yaghoub Sheikhi Ave, Leila kooh Road, Langroud
City
Langroud
Province
Guilan
Postal code
4477166595
Phone
+98 13 4256 5052
Email
pourghanep@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Parand Pourghane
Position
َAssociate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Zeynab School of Nursing and Midwifery, Yaghoub Sheikhi Ave, Leila Kooh Road
City
Langroud
Province
Guilan
Postal code
4477166595
Phone
+98 13 4256 5052
Email
pourghanep@gmail.com

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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