The effect of counseling with cognitive-behavioral approach on perceived stress in pregnant women with a history of primary infertility: a randomized controlled clinical trial
To determine the effect of counseling with cognitive-behavioral approach on perceived stress in pregnant women with a history of primary infertility
Design
randomized controlled clinical trial
Settings and conduct
The study will be conducted in AlZahra or Milad Infertility Clinic of Tabriz city on 56 women of 20-40 years old, impregnated using Assisted Reproductive Techniques (ART). The pregnant women who meet the study criteria will be selected using convenience sampling method, and, the perceived stress scale is completed by the researcher through interviewing the participants. Those who are scored 21.8 or more will be included in the study, and the written informed consent will be obtained. Then, the social and demographic characteristics questionnaire, Edinburgh depression during pregnancy scale, the Van den Bergh pregnancy anxiety questionnaire, and, the quality of life scale for pregnancy will be completed by the researcher through interviews. The participants are divided into intervention and control groups using randomized block design according to their age (20 to 30, and 31 to 40 years old), with a block size of 4 and 6.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
1-The history of primary infertility
Exclusion Criteria :
1. The history of self-reported mental illness
2. The history of self-reported chronic physical illness
Intervention groups
For the intervention group (n=28), cognitive-behavioral group counseling will be conducted at 6 in-person sessions of 60-90 min each, besides two telephone sessions once a week. The controls (n=28) will receive only the routine pregnancy care.
Main outcome variables
The main outcome variable is perceived stress, which will be measured before the intervention, and 8 weeks after intervention, using the Cohen's Perceived Stress Scale (PSS).
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111219008459N12
Registration date:2018-11-10, 1397/08/19
Registration timing:prospective
Last update:2018-11-10, 1397/08/19
Update count:0
Registration date
2018-11-10, 1397/08/19
Registrant information
Name
Shirin Hasanpoor
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
hasanpoorsh@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-11, 1397/08/20
Expected recruitment end date
2019-03-11, 1397/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of counseling with cognitive-behavioral approach on perceived stress in pregnant women with a history of primary infertility: a randomized controlled clinical trial
Public title
The effect of counseling on perceived stress in pregnant women with a history of primary infertility
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 20 and 40 years
The history of primary infertility
at least secondary education
Gestational age between the beginning of the 14th week and the end of the 20th week
Exclusion criteria:
Abnormalities in the fetus
The history of self-reported mental illness
The history of self-reported chronic physical illness (heart disease, hypertension, pulmonary disease, iron deficiency anemia, diabetes, thyroid disease, epilepsy)
The history of severe self-reported psychological crisis over the past 3 months, such as the death of relatives
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
The participants are divided into intervention and control groups using randomized block design according to their age (20 to 30, and 31 to 40 years old), with a block size of 4 and 6.In order to hide the allocation, the type of intervention will be written on paper and placed in matt and packed envelopes numbered.The envelopes will be opened in the order of participation of the participants and the type of group will be determined.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Research department, third floor,central construction number 2 , Tabriz University of Medical Sciences , Golgasht Street, Azadi Avenue ,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5168743953
Approval date
2018-10-22, 1397/07/30
Ethics committee reference number
1397-625
Health conditions studied
1
Description of health condition studied
perceived stress
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Perceived Stress
Timepoint
Before the intervention and four weeks after the intervention
Method of measurement
Kohen perceived stress questionnaire
Secondary outcomes
1
Description
Anxiety
Timepoint
Before the intervention and four weeks after the intervention
Method of measurement
PRAQ: Pregnancy related anxiety questionnaire
2
Description
Depression
Timepoint
Before the intervention and four weeks after the intervention
Method of measurement
Edinburghs Depression during Pregnancy questionnaire
3
Description
Quality of life
Timepoint
Before the intervention and four weeks after the intervention
Method of measurement
QOL-GRAV: Quality of life gravidarum
Intervention groups
1
Description
For the intervention group (n=28), cognitive-behavioral group counseling will be conducted at 6 in-person sessions of 60-90 min each, besides two telephone sessions once a week
Category
Other
2
Description
The controls (n=28) will receive only the routine pregnancy care.