Objective: This study is to determine the effect of music therapy counselling on sleep quality among primigravida women. This study is a semi experimental with two groups (experimental and control) with pre-test and post-test. This study comprised pregnant women attending to health care centers in Hamadan. Simple randomization will be done. The sample size is 44 women in the intervation group and 44 women in control group. Inclusion criteria: First pregnancy; single fetus and gestational age 30-34 weeks; having sleep disturbance(Pittsburgh scale 5 or more) Exclusion criteria: Any problems in pregnancy during the study period. In the intervention group music therapy counseling will be trained by the researcher in two sessions. The intervention group will listen to relaxing music CD for 4 weeks, once daily each night for 45 minutes before sleep. In this study primary outcome measure is sleep quality and secondary outcome measure is music therapy counseling.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201506216888N9
Registration date:2015-09-09, 1394/06/18
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-09-09, 1394/06/18
Registrant information
Name
Fatemeh Shobeiri
Name of organization / entity
Hamadan Universiy of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1827 6051
Email address
shobeiri@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor of Research Technolog, Hamedan University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-06-21, 1395/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of music therapy counseling on sleep quality among primigravida women
Public title
The effect of music therapy counseling on sleep quality among primigravida women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: The age range 18-35 years; first pregnancy and wanted pregnancy; single fetus and gestational age 30-34week; not being addicted; Not taking drugs affecting sleep quality; not having difficulty of hearing; Not taking antidepressants; ability to access to a music player at home; having sleep disturbance(Pittsburgh scale 5 or more); not having physical and mental disorders, according to the pregnancy records exclusion criteria: Any problems in pregnancy during the study period (abruption, fetal abnormal situation, cord prolapse, bleeding, diabetes, hypertension, preterm labor and ...); major mental and emotional changes (such as death or serious disputes)
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The participants will be divided into two groups by using simple randomization by using a table of random numbers.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Fahmiheh Street, Hamadan University of Medical Sciences, Hamadan, Iran
City
Hamadan
Postal code
65178
Approval date
2015-06-29, 1394/04/08
Ethics committee reference number
IR.UMSHA.REC.1394.189
Health conditions studied
1
Description of health condition studied
sleep
ICD-10 code
F51
ICD-10 code description
In many cases, a disturbance of sleep is one of the symptoms of another disorder, either mental or physical. Whether a sleep disorder in a given patient is an independent condition or simply one of the features of another disorder classified elsewhere, ei
Primary outcomes
1
Description
Sleep quality
Timepoint
weeks 30-34 and 34-38 of gestational age
Method of measurement
Pittsburgh Sleep Quality Index (PSQI)
Secondary outcomes
1
Description
music therapy
Timepoint
week 34-38 of gestational age
Method of measurement
Checklist
Intervention groups
1
Description
listening to relaxing music at home from 30-34 weeks for 4 weeks, each night for 45 minutes each time
Category
Other
2
Description
The control group will receive regular prenatal care
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Healthcare center Samii 9
Full name of responsible person
Susan Khaledi
Street address
Madani settlements
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor of Research Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr. Bashirian Saeed
Street address
Fahmiheh Street, Hamadan University of Medical Sciences, Department of Research and Technology
City
Hamadan
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor of Research Technology, Hamadan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Hamadan University of Medical sciences
Full name of responsible person
Fatemeh Shobeiri
Position
Ph.D. in Maternal and Child Health
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave, Hamadan
City
Hamadan
Postal code
۶۵۱۶۸۴۵۹۷۷
Phone
+98 81 3827 6051
Fax
Email
shobeiri@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of Medical sciences
Full name of responsible person
Fatemeh Shobeiri
Position
Ph.D. in Maternal and Child Health
Other areas of specialty/work
Street address
Hamadan University of Medical sciences, School of Nursing and Midwifery, Fahmideh Ave, Hamadan
City
Hamadan
Postal code
۶۵۱۶۶۴۵۹۷۷
Phone
+98 81 3827 6051
Fax
Email
shobeiri@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University of Medical sciences
Full name of responsible person
Fatemeh Shobeiri
Position
Ph.D. in Maternal and Child Health
Other areas of specialty/work
Street address
Hamadan University of Medical sciences, School of Nursing and Midwifery, Fahmideh Ave, Hamadan
City
Hamadan
Postal code
۶۵۱۶۶۴۵۹۷۷
Phone
+98 81 3827 6051
Fax
Email
shobeiri@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)