Evaluating the effect of sleep health education and music therapy on sleep quality in patients with multiple sclerosis
Design
Clinical trial without control group, without blinding, sample size of 50 people continuously
Settings and conduct
In the MS Association, people with inclusion criteria are selected in a continuous manner. After reaching the sample size, they are divided into four groups and the training of these four groups is done in one day but at different hours. After completing the pre-test questionnaire, the necessary training on how to use music for listening for two weeks is given every night for 30-45 minutes before going to bed without headphones. Also, explanations about sleep hygiene are provided in person. And the music will be provided to the samples and will be filled after the end of the post-test intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Having a smart phone؛ Literate؛ No hearing impairment ؛PSQI score greater than five؛ Ages between 20 to 40 years؛ Absence of relapse and exacerbation of symptoms؛ No communication and cognitive problems ؛Absence of patients other than multiple sclerosis
Exclusion criteria:
Do not listen to music for 3 consecutive or intermittent nights؛ Reluctance to continue participation؛ Patients who have known serious physical and mental disorders and illnesses during the intervention؛ Changes in treatment and medications؛ Recurrence of the disease؛ Participate in programs or treatments that affect sleep simultaneously؛ Death
Intervention groups
The intervention includes music therapy in the form of listening to music for 30-45 minutes two weeks each night before bed and sleep hygiene training.
Main outcome variables
improve the quality of sleep
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211023052853N1
Registration date:2021-11-16, 1400/08/25
Registration timing:prospective
Last update:2021-11-16, 1400/08/25
Update count:0
Registration date
2021-11-16, 1400/08/25
Registrant information
Name
Fatemeh Sadeghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4613 8509
Email address
fatemeh.sadeghi.1393@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-22, 1400/10/01
Expected recruitment end date
2022-04-19, 1401/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluate the effects of Sleep hygiene education and music therapy on sleep quality in clients with multiple sclerosis (MS)
Public title
the effects of Sleep hygiene education and music on sleep quality in clients with MS
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having a smart phone with the ability to play music and have a social network and the ability to use it
Literate
No hearing impairment
PSQI score greater than five
Ages between 20 to 40 years
Absence of relapse and exacerbation of symptoms
No communication and cognitive problems (with patient comments and records)
Absence of patients other than multiple sclerosis
Exclusion criteria:
Known serious physical-mental illness
Participate in programs or treatments that affect sleep
Age
From 20 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Unit 7, No. 2,Dariush Dead End, Shabboo Alley, Besarati St, Shahin Shomali Ave, Janatabad
City
Tehran
Province
Tehran
Postal code
1475775931
Approval date
2021-10-26, 1400/08/04
Ethics committee reference number
IR.IUMS.REC.1400.665
Health conditions studied
1
Description of health condition studied
Multiple Sclerosis (MS)
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
Sleep quality score on the Pittsburgh questionnaire
Timepoint
Before the intervention and 14 days after the intervention
Method of measurement
Pittsburgh Sleep Quality Index (PSQI)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: To conduct this research, which is a one-group quasi-experimental study with pre-test-post-test, the researcher after obtaining permission from the ethics committee and obtaining permission to conduct research from Iran University of Medical Sciences due to corona pandemic in full compliance with protocols Behdashti refers to the research environment, which is the Iranian Inflammatory Association, and after coordinating with the relevant officials in the Inflammatory Association and obtaining permission from them in that center, the research objectives will be fully explained to them, and If they wish to participate in the research, the informed consent form will be completed by them. Selects those who have the criteria to enter the research in a continuous manner, which is based on the statistical formula of 50 people. After reaching the sample size due to the corona pandemic, training of the samples is done in a suitable space by observing the distance and health protocols in person. Due to the large number of samples for better teaching and learning and observing the social distance, the samples are divided into four groups and training of these four groups is done in one day but at different hours. Coordination with the samples is done for the date and time of the training session. After the pre-test session, which includes two questionnaires: 1- Demographic information and 2- Pittsburgh questionnaire, it is completed in person at the Emas Association. The time allotted for filling out this questionnaire is 5-10 minutes. Then, after collecting questionnaires about sleep hygiene and how to use music, the necessary training in person, which includes lying down in a comfortable position and closing your eyes before listening to non-verbal and soothing music and focusing on it. The mental opinion that is accompanied by the sound of nature should be mentioned. It should be mentioned that music is without words and only the sound of nature and has a license from the Ministry of Guidance. 30 minutes before bedtime is given without headphones. Also, explanations about sleep hygiene are provided in person. Before going to bed, use the bed only for sleep and sex, do not take a nap during the day, take a shower, do not watch the clock, exercise, eat a healthy and balanced diet, a good atmosphere, maintain a daily schedule. The instructional booklet and music without words will be provided to the samples. In addition, the researcher's contact phone will be provided to the samples to remove any ambiguity and questions, so that the researcher can follow up by phone to control the condition of the samples. Post-test intervention will be filled electronically by the sample due to the prevalence of coronary pandemic. After collecting the questionnaires, data and scores related to each section of the questionnaire are calculated.