Effect of Music Therapy on Pain Intensity and Sleep Quality of Patients with Multiple Sclerosis.
Design
This study is a clinical trial type between two control and intervention groups in parallel and without blinding, randomized, on 60 patients. STATA software is used for randomization.
Settings and conduct
The Place of Implementation of the study is the Comprehensive Center for MS Patients in Ghaem Hospital in Mashhad. The research population includes Multiple Sclerosis patients. Blinding was not done in this study.
Participants/Inclusion and exclusion criteria
Inclusion Criteria include Patients with MS who have been Diagnosed with Relapsing-Remitting type of the Disease for a Year. Exclusion Criteria include Not Wanting to Participate in the Study and Changing the Course of Disease Recurrence.
Intervention groups
In the intervention group, people listened to the selected wordless music for 14 days, three times a day (morning between 7 and 9, evening between 4 and 6, night between 9 and 11) and each time for 15- They will listen for 10 minutes while waking up or resting. The control group will receive only their routine treatments prescribed by their doctor. Questionnaires will be completed by people before the intervention and 14 days after the intervention.
Main outcome variables
Pain Intensity; Sleep Quality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231001059576N1
Registration date:2023-11-04, 1402/08/13
Registration timing:prospective
Last update:2023-11-04, 1402/08/13
Update count:0
Registration date
2023-11-04, 1402/08/13
Registrant information
Name
Milad Rezaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5224 1503
Email address
rezaeiml4001@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-01, 1402/09/10
Expected recruitment end date
2024-02-29, 1402/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Music Therapy on Pain Intensity and Sleep Quality of Patients with Multiple Sclerosis
Public title
The Effect of Music on Pain Intensity and Sleep Quality
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Refer to the Comprehensive Center for MS patients located in Qaem Hospital
Diagnosis of Multiple Sclerosis by a Specialist Doctor in the last year
Age between 20 and 50 Years
Patients with Relapsing-Remitting MS who are in the Recovery Phase of the Disease
Extended Disability Status Scale or EDSS between 0 and 5.5
Undesirable of Sleep Quality based on the Pittsburgh Sleep Quality (score above 5)
No addiction
Not Regularly Listening to a Particular Style of Music
Exclusion criteria:
Unwillingness to Continue Participating in Research
Not listening to Music for 3 Nights in a Row or Alternately
Changing the Process of Disease Recurrence
Suffering from other Acute or Chronic Debilitating Diseases or Mental Disorders
Taking Sleeping Pills
The Presence of a Musician among those who live with the Patient under the Same Roof
Employment in the music profession
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The random sequence is generated by STATA software. Then this sequence is written on small cards and placed in the closed envelope. Every qualified person who entered the study, the door of the envelope is opened and based on the code on the card, he is placed in one of two groups. This method continues until all people are assigned to two groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The method of choosing the desired theme will be based on Schubert's articles regarding the feeling of musical steps. In this way, after selecting the desired Music determined by the researcher and a music expert, they will be placed in their desired theme group. The reason for choosing three types of happy, sad and invigorating themes is the effect of these themes on people's mood, which according to past research studies, happy themes are rhythmic pieces with a relatively sharp melody that bring vitality and vitality. It inspires excitement and impatience and is associated with stability and calm; Sad themes are sad and glorious and evoke sadness, failure, sorrow and regret in the listener. Sad themes by stimulating and associating memories and releasing sad feelings cause sympathy and relief. Invigorating themes, powerful rhythm and stimulating melodies with a positive and pleasant feeling give more energy and strength than what excites the spirit. These pieces, like a pleasant and pleasant shock, turn depression, laziness and lethargy into mobility and create a feeling of ability, mastery and determination. In general, the purpose of choosing the music was to start softly and end with hope and excitement after creating a sense of unity.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Faculty of Nursing and Midwifery - Mashhad University of Medical Sciences
Street address
Educational Complex of Shahid Dr. Kharazmi, University Campus, east gate of Ferdowsi University of Mashhad, Azadi Square, Mashhad, Khorasan Razavi
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2023-10-17, 1402/07/25
Ethics committee reference number
IR.MUMS.NURSE.REC.1402.089
Health conditions studied
1
Description of health condition studied
Patients with Relapsing-Remitting Multiple Sclerosis who are in the Recovery Phase.
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
Pain Intensity
Timepoint
Pain Intensity will be Measured in the Research Units Participating in the study at the Beginning of the Study (Before the Start of the Intervention) and 14 Days After the Start of the Intervention.
Method of measurement
In this study, Pain Intensity will be Measured Using the McGill Pain Questionnaire
2
Description
Sleep Quality
Timepoint
Pain Intensity will be Measured in the Research Units Participating in the study at the Beginning of the Study (Before the Start of the Intervention) and 14 Days After the Start of the Intervention.
Method of measurement
In this study, Sleep Quality will be Measured Using the Pittsburgh Sleep Quality Index
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with Multiple Sclerosis who will Receive Music Therapy in Addition to their Medications Prescribed by their Doctor. Music Therapy is Performed Three Times a Day for Two Weeks (Morning between 7 and 9, Evening between 4 and 6 and Night between 9 and 11) and each time for 10 to 15 Minutes During Waking hours. Or they will Rest and Listen to the Silent Music in Three Themes, Joyful, Sad and Invigorating, Composed by Iranian and Foreign Composers and Approved by Experts and Experts.
Category
Treatment - Other
2
Description
Control group: In this Group, They Will Take the Usual Treatment Interventions Prescribed by Their Doctor, And Music Therapy will not be Done for this group.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive Center for MS Patients
Full name of responsible person
Hamid Reza Zendehtalab
Street address
Between Parastar 3 and 5, Parastar Ave, Ahmadabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
+98 51 3840 0001
Email
b.ghaem@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Research and Technology Vice-Chancellor of Mashhad University of Medical Sciences, Second Floor, Qureshi Building, Front of 16 University Ave, University Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
Tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Hamid Reza Zendehtalab
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Educational Complex of Shahid Dr. Kharazmi, University Campus, East Gate of Ferdowsi University of Mashhad, Azadi Square, Mashhad, Khorasan Razavi
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
ZendehtalabHR@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Milad Rezaei
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 11, 7 Imam Khomeini Ave, Imam Khomeini Blvd
City
Torbat-e Heydariyyeh
Province
Razavi Khorasan
Postal code
9513643885
Phone
+98 51 5224 1503
Fax
Email
rezaeiml4001@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Milad Rezaei
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 11, 7 Imam Khomeini Ave, Imam Khomeini Blvd
City
Torbat-e Heydariyyeh
Province
Razavi Khorasan
Postal code
9513643885
Phone
+98 51 5224 1503
Fax
Email
rezaeiml4001@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
All the data obtained from this research will be shared after completion.
When the data will become available and for how long
Access to the data will be possible 3 months after the results are published.
To whom data/document is available
These data will be used for researchers working in academic and scientific institutions, as well as for people with multiple sclerosis.
Under which criteria data/document could be used
The data obtained from this research can be used in other scientific studies.
From where data/document is obtainable
Copying (in any way) either from the full text or from the extracts is possible only with the coordination of the supervisor and the registered author and according to the instructions provided by the Central Library of Mashhad University of Medical Sciences. Details can be accessed through the relevant faculty library. The use of the thesis in articles or any scientific writing is subject to citing the source in compliance with the Mashhad University of Medical Sciences publishing regulations.
Hamid Reza Zendehtalab: ZendehtalabHR@mums.ac.ir
Milad Rezaei: Rezaeiml4001@mums.ac.ir
What processes are involved for a request to access data/document
The applicant should send an email to the responsible author and register his request. After verifying the correctness of the information of the mentioned person, the required content will be provided to him by mentioning the source.