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Effectiveness of Cognitive Behavioral Therapy and Haptonomy on fear of childbirth, Birth Experiences and postpartum depression in Nulliparous Pregnant Women: A Randomized Controlled Clinical Trial

Protocol summary

Study aim
Determine the effect of cognitive behavioral therapy (CBT) and haptonomy on fear of childbirth, birth experience and postpartum depression in nulliparous pregnant women
Design
A RCT with 3 parallel groups, non-blind will be conducted on 99 women at gestational age of 24-28 weeks. The participants will be assigned into three groups by blocked randomization and the allocation ratio of 1:1:1.
Settings and conduct
Sampling will be done in 4 health complexes of Tabriz. The fear of childbirth, depression and their preferred type of delivery will be measured in 24-28 weeks. At 35-37 weeks, fear of birth and their preferred type of delivery will be measured. One month after delivery, fear, childbirth experiences and postpartum depression and type of delivery will be assessed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Primiparous women aged 18-45 years at gestational age of 24-28 weeks, Fear of birth score above 65 based on Wijma. Exclusion criteria: History of psychological disorders, Known fetal abnormality, Unplanned pregnancies, History of participating in physiological birth classes, History of recurrent miscarriages, Pregnancy with artificial reproductive techniques.
Intervention groups
In CBT group, from 24-28 weeks, counseling about introducing thought, feeling and behavior cycle, and relaxation will be offered once a week in 8 sessions. In haptonomy group, communication techniques will be taught in 5 sessions including positive feelings towards pregnancy, methods of labor pain control, and helping to change the mind. The control group will receive routine pregnancy care.
Main outcome variables
Mean score of fear of childbirth, birth experience and postpartum depression

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170506033834N9
Registration date: 2022-01-02, 1400/10/12
Registration timing: prospective

Last update: 2022-01-02, 1400/10/12
Update count: 0
Registration date
2022-01-02, 1400/10/12
Registrant information
Name
Roghaiyeh Nourizadeh
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3479 6770
Email address
nourizadehr@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-05, 1400/10/15
Expected recruitment end date
2022-08-11, 1401/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Cognitive Behavioral Therapy and Haptonomy on fear of childbirth, Birth Experiences and postpartum depression in Nulliparous Pregnant Women: A Randomized Controlled Clinical Trial
Public title
Effectiveness of Cognitive Behavioral Therapy and Haptonomy on fear of childbirth, Birth Experiences and postpartum depression in Nulliparous Pregnant Women: A Randomized Controlled Clinical Trial
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Primiparous women aged 18-45 years Gestational age of 24-28 weeks Fear of childbirth score above 65
Exclusion criteria:
History of mental disorders according to the mother statement Known fetal abnormalities Unplanned pregnancy History of participating in physiological birth classes History of recurrent miscarriages or pregnancies with artificial reproductive techniques
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 99
Randomization (investigator's opinion)
Randomized
Randomization description
Participants randomly using RAS software through stratified random blocking based on high and severe fear with 6 and 9 blocks into three groups with a ratio of 1:1:1 (in Each group 33 people) will be assigned. The allocation type will be written on paper and numbered in consecutive opaque envelopes (Allocation Concealment). The envelopes will be opened sequentially by the person not involved in the sampling.
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
Faculty of Nursing and Midwifery, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Approval date
2021-11-01, 1400/08/10
Ethics committee reference number
IR.TBZMED.REC.1400.678

Health conditions studied

1

Description of health condition studied
Postpartum depression
ICD-10 code
O90.6
ICD-10 code description
Postpartum mood disturbance

2

Description of health condition studied
Fear of childbirth
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Fear of childbirth score
Timepoint
Before the intervention in 24-28 gestational week, 35-37 weeks of pregnancy and one month after delivery
Method of measurement
Wijma delivery expectancy/experience questionnaire (versions of A & B)

2

Description
Childbirth experience score
Timepoint
One month after delivery
Method of measurement
Childbirth Experiences Questionnaire version 2.0(CEQ-2.0)

3

Description
Postpartum depression
Timepoint
Before the intervention in 24-28 weeks and one month after delivery
Method of measurement
Edinburgh Postpartum Depression Scale (EPDS)

Secondary outcomes

1

Description
Preferred delivery type
Timepoint
Before the interventions at gestational age of 24-28 weeks and again in 35-37 weeks.
Method of measurement
Ask the mother about preferred delivery type

2

Description
Method of delivery
Timepoint
One month after delivery
Method of measurement
Medical record

Intervention groups

1

Description
Intervention group 1: In the group of cognitive-behavioral intervention from the 24- 28 weeks, counseling in groups of three to six people in eight sessions (combination of face-to-face and online sessions) will be held and each session will be for 45 to 60 minutes, once a week. The content of counseling mainly includes teaching the process of pregnancy and childbirth, expressing the benefits and harms of vaginal birth and cesarean section, teaching the birth stages and process, identifying thoughts, introducing thought, feeling and behavior cycle, providing coping exercises and prevention of inappropriate behaviors and thoughts, training distraction technique, training abdominal breathing, relaxation and Kegel exercises, training in the technique of changing mental images and training to deal with the return of previous behaviors and attitudes.
Category
Behavior

2

Description
Intervention group 2: In haptonomy group, communication techniques will be taught from 24 to 28 gestational week, in groups of 3 to 6 people in 5 sessions, a combination of face-to-face and online sessions, each session lasting 45-60 minutes, once a week. The content of intervention mainly includes strengthening positive feelings and attitudes towards pregnancy, identifying worries about pregnancy and childbirth and helping to solve fears and worries, teaching communication methods such as talking to the fetus, observing and touching Abdomen, attention to fetal movements and training fetal movement counting, advice to name the fetus , teaching various methods of controlling labor pain, showing the effect of pregnancy hormones on anatomical changes of the pelvis, helping to change the mind with understanding the pregnancy process and Delivery and evaluation of the birth schedule.
Category
Behavior

3

Description
The control group will receive only routine prenatal care.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Eram health center
Full name of responsible person
Roghaiyeh Nourizadeh
Street address
Almahdi Street, region 8, Eram Town
City
Tabriz
Province
East Azarbaijan
Postal code
041-33808025
Phone
+98 41 3232 5127
Email
rnourizadeh@gmail.com
Web page address

2

Recruitment center
Name of recruitment center
Bavafa health center
Full name of responsible person
Roghaiyeh Nourizadeh
Street address
Infront of Asad-Abadi hospital, Bahar Street
City
Tabriz
Province
East Azarbaijan
Postal code
5613974156
Phone
+98 41 3280 1471
Email
alivand.zahraa@gmail.com
Web page address

3

Recruitment center
Name of recruitment center
Asad-Abadi health center
Full name of responsible person
Roghaiyeh Nourizadeh
Street address
Monajjem Blvd
City
Tabriz
Province
East Azarbaijan
Postal code
5613974156
Phone
+98 41 3266 8203
Email
alivand.zahraa@gmail.com
Web page address

4

Recruitment center
Name of recruitment center
Sadi health center
Full name of responsible person
Roghaiyeh Nourizadeh
Street address
Pastor Street
City
Tabriz
Province
East Azarbaijan
Postal code
5613974156
Phone
+98 41 3476 7353
Email
alivand.zahraa@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Parviz Shahabi
Street address
Central Building; Tabriz University; Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5613974156
Phone
+98 41 3335 7310
Email
parvizshahabi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Zahra Alivand
Position
Master student of counseling in midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, South Shariati StreetTabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
alivand.zahraa@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Roghaiyeh Nourizadeh
Position
Ph.D in Reproductive Health
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Nursing and Midwifery Faculty, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
041-33808025
Phone
+98 41 3479 6770
Email
rnourizadeh@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Roghaiyeh Nourizadeh
Position
Ph.D in reproductive health
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Faculty of Nursing and Midwifery, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
6615615733
Phone
+98 41 3479 0364
Email
nourizadehr@tbzmed.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more data
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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