The effectiveness of midwifery counseling based on Logo-therapy on anxiety and breastfeeding self-efficacy after breastfeeding Trauma
Design
Clinical trial with 80 sample people and randomly assigning people to control and intervention groups
Settings and conduct
Eslamshar Emamreza Hospital
Participants/Inclusion and exclusion criteria
inclusion criteria: first birth, has not experienced an incident such as the death of a loved one, betrayal, divorce in the last month,confirmation of breastfeeding trauma according to the checklist, a person with a history of breast surgery that causes tissue damage ,the person has a desire to breastfeed,the score obtained from the Spielberger overt anxiety questionnaire should be 20-60,the baby should be healthy (no abnormality - not hospitalized,The person does not currently have a psychiatric disorder or a history of a psychiatric disorder for which she has visited a psychiatrist or taken medication, At least 4-6 weeks and at most three months have passed since childbirth.
Exclusion criteria:mental disorder or having a history of mental disorder for which he has been referred to a psychiatrist and confirmed by him, consumption or history of taking psychiatric drugs,a score obtained from Spielberger overt anxiety questionnaire between 61 and be 80
Intervention groups
The intervention group: 40 women whose breastfeeding trauma has been confirmed according to the checklist and whose Spielberger manifest anxiety score is between 20 and 60. The people in the intervention group have 4 sessions of 60-minute meaning therapy counseling in groups of 8.they will receive routine postpartum care. The control group :40 women who have been confirmed to have breastfeeding trauma according to the checklist. And their Spielberger anxiety score is between 20 and 60.
Main outcome variables
Anxiety and Breastfeeding Self-Efficacy after Breastfeeding Trauma
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231202060241N1
Registration date:2023-12-16, 1402/09/25
Registration timing:prospective
Last update:2023-12-16, 1402/09/25
Update count:0
Registration date
2023-12-16, 1402/09/25
Registrant information
Name
Maryam Rahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2249 3576
Email address
rahimi.maryam13@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-22, 1402/10/01
Expected recruitment end date
2024-02-20, 1402/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating of the effectiveness of midwifery counseling based on Logo-therapy on anxiety and breastfeeding self-efficacy after breastfeeding Trauma
Public title
Effectiveness of Logo-Therapy on Anxiety and Breastfeeding Self-efficacy after Traumatic Breastfeeding
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
First Child
In the last month,Their has not experienced an incident such as the death of loved ones, betrayal, or divorce
Confirmation of traumatic breastfeeding according to the checklist
They have not a history of surgery on the breast that caused tissue damage and inability to breastfeed.
Tend to breastfeeding
Exclusive Breastfeeding
The score obtained from Spielberger overt anxiety questionnaire should be 20-60
The Newborn should be healthy (no abnormality - not hospitalized)
At least 4-6 weeks and at most three months have passed since Delivery
They currently Dont have a psychiatric disorder or a history of a psychiatric disorder or take medication.
Exclusion criteria:
Mental disorder or having a history of mental disorder .
Use or history of taking psychiatric medication
The score obtained from the Spielberger overt anxiety questionnaire be between 61 and 80
Age
From 10 years old to 54 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Shahroud University of Medical Sciences
Street address
No 13, Kowsar tower , Artesh High way, Tehran city
City
Tehran
Province
Tehran
Postal code
1955856915
Approval date
2023-11-28, 1402/09/07
Ethics committee reference number
IR.SHMU.REC.1402.139
Health conditions studied
1
Description of health condition studied
Traumatic Breastfeeding
ICD-10 code
O99.3
ICD-10 code description
Mental disorders and diseases of the nervous system complicating pregnancy, childbirth and the puerperium
Primary outcomes
1
Description
Anxiety after Traumatic Breastfeeding
Timepoint
Before Intervention, After Intervention, Two Month after end of Intervention
Method of measurement
Spielberger State-Trait Anxiety Inventory
Secondary outcomes
1
Description
Breastfeeding Self-efficacy
Timepoint
Before Intervention, After Intervention, Two Month after end of Intervention
Method of measurement
Denis Breastfeeding Self- Efficacy scale
Intervention groups
1
Description
Intervention group: The intervention group includes 40 mothers who are breastfeeding and 4-6 weeks to three months have passed since their delivery and have experienced Traumatic Breastfeeding. The intervention is midwifery counseling based on Logo-therapy in 4 sessions and each session take 60 minutes in groups of 8 people, in order to Evaluation the effectiveness of the midwifery counseling based on Logo-therapy on the anxiety and breastfeeding self-efficacy in women who suffer from Traumatic Breastfeeding, once a week and during a month + routine postpartum care will be done for women who are in the intervention group.
Category
Treatment - Other
2
Description
Control group: The control group includes 40 mothers who are breastfeeding and 4-6 weeks to three months have passed since their delivery and have experienced Traumatic Breastfeeding, and they take only routine postpartum care.