Determining the effect of massage by husband in pregnancy on pregnancy stress and postpartum grief in primiparous mothers referred to comprehensive health centers in Isfahan
Design
Randomized clinical trial with control group; single blind; on 42 patients. Even and odd numbers will be used for randomization
Settings and conduct
Study place: Health Center;
Study population: Pregnant mothers referring to health center;
Type of blinding: One-way blinding;
How to blind: The clinician does not know for which group the massage was performed and for which group the massage was not performed.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
First pregnancy; Gestational age 30-30 weeks; Singleton pregnancy; Spouse is available (no job assignments).
Non-inclusion criteria:
History of specific underlying diseases; pregnancy problems (placenta previa, history of preterm delivery, collage head, fetal abnormalities); mental illness; Score 8-12 from DASS21 questionnaire
Intervention groups
The intervention group is pregnant mothers on whom massage is performed.
The control group is pregnant mothers who are not massaged.
Main outcome variables
Pregnancy stress; Postpartum blues
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211219053456N1
Registration date:2022-02-02, 1400/11/13
Registration timing:registered_while_recruiting
Last update:2022-02-02, 1400/11/13
Update count:0
Registration date
2022-02-02, 1400/11/13
Registrant information
Name
roya hoseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3776 7885
Email address
royah2143@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-25, 1400/11/05
Expected recruitment end date
2022-02-24, 1400/12/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the husband massage effect on pregnancy stress and postpartum blues in primiparous women
Public title
The husband massage effect in pregnancy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
First pregnancy
Gestational age 32-30 weeks
Singleton
Spouse available (no job assignments)
Score 12-8 from DASS21 questionnaire
Exclusion criteria:
History of specific underlying diseases
Pregnancy problems (placenta previa, history of preterm delivery, cerclage, fetal abnormalities)
Presence of mental illness
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
Care provider
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
We put even and odd numbers in a sealed envelope and then every mother picks up a number at random.
Blinding (investigator's opinion)
Single blinded
Blinding description
The clinician does not know who is in the intervention group or who is in the control group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commitee of Isfahan University of Medical Sciences
Street address
No.88; Karimian alley; Bagh-Daryacheh street
City
Isfahan
Province
Isfehan
Postal code
8176757791
Approval date
2021-10-30, 1400/08/08
Ethics committee reference number
IR.MUI.NUREMA.REC.1400.165
Health conditions studied
1
Description of health condition studied
pregnancy strees
ICD-10 code
O99.344
ICD-10 code description
Other mental disorders complicating childbirth
2
Description of health condition studied
postpartum blues
ICD-10 code
O90.6
ICD-10 code description
Postpartum mood disturbance
Primary outcomes
1
Description
The stress score in the Dass-21 questionnaire
Timepoint
31 th and 37 th week of pregnancy
Method of measurement
Dass-21 questionnaire
2
Description
Postpartum bluse score in Edinburgh questionnaire
Timepoint
3 to 10 days after delivery
Method of measurement
Edinburgh questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Pregnant mothers are in 32th weeks of GA in the intervention group, who are massaged from 32-37 weeks. External hand down also the inner surface of the foot upwards from the outer surface of the foot downwards then from the bottom of the spine upwards and then towards the shoulders and again towards the spine and then downwards to the spine which for 20 minutes, three times a week for 5 weeks (15 sessions in total) This massage will be done by sweet almond oil for the mother.
Category
N/A
2
Description
Control group: Pregnant mothers are at 32th-37th week of GA without massage