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Effect of Acceptance and Commitment Therapy (ACT) on Mental health and breastfeeding self efficacy in mothers with premature infant: A Controlled Randomized Trial

Protocol summary

Study aim
Effect of Acceptance and Commitment Therapy (ACT) on Mental health and breastfeeding self efficacy in mothers with premature infant
Design
A randomized controlled clinical trial with two parallel arms
Settings and conduct
This study will be performed on 90 mothers with premature infants less than 37 weeks old in Al-Zahra and Taleghani educational and medical centers of Tabriz. Mothers will be evaluated based on eligible criteria and if they have the criteria and desire to participate in the study, written informed consent will be obtained and initial assessments will be made. Participants using random blocking method with the size of 4 and 6 blocks. And will be assigned to the two groups of consulting and control with a 1: 1 allocation ratio.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Primiparous mothers, Newborn between 37-33 weeks old and Having the ability to breastfeed, Establish breastfeeding Exclusion criteria: Use of drugs, tobacco, alcohol and herbal medicines, Use of any antidepressant such as sertraline, fluoxetine, venlafaxine, antihistamines, barbiturates, narcotics, diazepam, amphetamines, cocaine, according to the mother, Score higher than the cut-off point of the DASS 21 questionnaire (severe and very severe), Existence of contraindications to breastfeeding
Intervention groups
For the intervention group, group counseling with the approach of acceptance and commitment therapy will be held in 8 sessions of 60 minutes, twice a week. The control group will receive routine interventions.
Main outcome variables
The main outcome variable is mental health.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210510051245N1
Registration date: 2021-05-31, 1400/03/10
Registration timing: prospective

Last update: 2021-05-31, 1400/03/10
Update count: 0
Registration date
2021-05-31, 1400/03/10
Registrant information
Name
Fatemeh Khajeh talkhooncheh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3479 6770
Email address
f.e.kh.198695@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-01, 1400/03/11
Expected recruitment end date
2021-10-03, 1400/07/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Acceptance and Commitment Therapy (ACT) on Mental health and breastfeeding self efficacy in mothers with premature infant: A Controlled Randomized Trial
Public title
Effect of Acceptance and Commitment Therapy (ACT) on Mental health and breastfeeding self efficacy in mothers with premature infant
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Primiparous mothers Newborn between 37-33 weeks old and Having the ability to breastfeed Establish breastfeeding
Exclusion criteria:
Use of drugs, tobacco, alcohol and herbal medicines Use of any antidepressant such as sertraline, fluoxetine, venlafaxine, antihistamines, barbiturates, narcotics, diazepam, amphetamines, cocaine, according to the mother Score higher than the cut-off point of the DASS 21 questionnaire (severe and very severe) Existence of contraindications to breastfeeding
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be assigned to two groups (one counseling group and one control group) by random block method and block size of 4 and 6 blocks with a 1: 1 allocation ratio. The allocation type will be written on paper and numbered in a series of opaque envelopes (Allocation cocealment). The envelopes will be opened in the order in which the participants enter the study. Envelopes will be prepared by a person not involved in sampling. Preparation of envelopes will be done by a person not involved in sampling And data collection and analysis will be performed.
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
Medical Ethics Committee of Tabriz University of Medical Sciences
Street address
Tabriz, Azadi St., Golgasht St., Tabriz University of Medical Sciences, Central Building No. 2, Third Floor, Research Deputy
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Approval date
2021-05-26, 1400/03/05
Ethics committee reference number
IR.TBZMED.REC.1400.200

Health conditions studied

1

Description of health condition studied
Mental health
ICD-10 code
F48.9
ICD-10 code description
Nonpsychotic mental disorder, unspecified

2

Description of health condition studied
breastfeeding self efficacy
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Anxiety, stress and depression
Timepoint
At the beginning of the study and immediately after the consultation sessions
Method of measurement
DASS-21 questionnaire

Secondary outcomes

1

Description
Breastfeeding self-efficacy
Timepoint
At the beginning of the study and then immediately after the end of the counseling sessions
Method of measurement
Breastfeeding self-efficacy questionnaire

Intervention groups

1

Description
Intervention group: In this study, group counseling in 8 sessions of 60 minutes with the approach of acceptance and commitment therapy will be done twice a week with participants. Content of counseling includes stating goals, introducing counseling based on acceptance and commitment to treatment, brief description of mental health, causes of premature birth and strategies to increase breast milk, identifying people's values, frustration technique using metaphor of well and shovel, techniques Suppression of thought, teaching the concept of acceptance, acquaintance with the concept of values and committed actions, practicing contact with the present, studying the story of life and committed action.
Category
Behavior

2

Description
Control group: Participants in the control group will receive routine care.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Al-Zahra Educational and Medical Center
Full name of responsible person
Sevil Hakimi
Street address
South Shariati Street , Faculty of Nursing & Midwifery
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
f.e.kh.198695@gmail.com

2

Recruitment center
Name of recruitment center
Taleghani Educational and Medical Center
Full name of responsible person
Sevil Hakimi
Street address
South Shariati Street , Faculty of Nursing & Midwifery
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
f.e.kh.198695@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Samii
Street address
Tabriz, Golgasht St., Tabriz University of Medical Sciences, Central Building No. 2, Research Deputy of Tabriz city
City
Tabriz
Province
East Azarbaijan
Postal code
5138947979
Phone
+98 41 3479 6969
Email
iro@tbzmed.ac.ir
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
Fatemeh Khajeh Talkhooncheh
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
South Shariati Street , Faculty of Nursing & Midwifery
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Fax
+98 41 3475 2839
Email
f.e.kh.198695@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sevil Hakimi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
South Shariati Street , Faculty of Nursing & Midwifery
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Fax
+98 41 3475 2839
Email
hakimis@tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sevil Hakimi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
South Shariati Street , Faculty of Nursing & Midwifery
City
Tabriz
Province
East Azarbaijan
Postal code
5138947979
Phone
+98 41 3479 6770
Fax
+98 41 3475 2839
Email
hakimis@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
Participant data is confidential.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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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