Evaluating the effects of midwifery counseling in Gamble's method on the women's self-efficacy and ability to cope with the first abortion
Design
The present study is randomized controlled trial with a control group, in which the samples are 100 women with the first abortion who meet the inclusion criteria according to the inclusion criteria.The type of sampling is random and parallel using block randomization method and table of random numbers which samples are non-blind with two groups of intervention(50 people) and control (50 people) are divided.
Settings and conduct
The researcher continuously visits Kamali Educational and Medical Center in Karaj every morning and invites primiparous women who have recently experienced abortion to participate in the study and the table will be assigned to two groups of 50 intervention and control.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women with spontaneous abortion and therapeutic abortion, no use of antidepressants and psychotropic drugs before and after abortion, no history of attending counseling classes according to the mother, no occurrence of a tragic accident in the last 6 months according to the mother, no Attend a counseling session ؛ Exclusion criteria: history of infertility, history of recurrent miscarriage, having a physical and mental illness affecting abortion.
Intervention groups
The two groups of 50 people are intervention and control. In addition to routine services, the routine care control group and the intervention group will receive face-to-face counseling based on the Gamble counseling model. The intervention group will receive counseling in 2 sessions of 45-75 minutes, the first session during the first 72 hours and the second session one month after abortion.
Main outcome variables
Coping strategies; Self efficacy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210221050437N1
Registration date:2021-09-28, 1400/07/06
Registration timing:retrospective
Last update:2021-09-28, 1400/07/06
Update count:0
Registration date
2021-09-28, 1400/07/06
Registrant information
Name
Farzane Hasanzade Tahraband
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3330 8904
Email address
hasanzadefarzaneh1990@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-27, 1400/01/07
Expected recruitment end date
2021-09-22, 1400/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of midwifery counseling based on Gamble approach on coping strategies and self-efficacy of women with the first abortion
Public title
"The effect of midwifery counseling in Gamble's method on the women's self-efficacy and their coping with first abortion"
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Women with spontaneous abortion and therapeutic abortion
Taking no antidepressants or psychotropic drugs before and after abortion
No history of attending counseling classes, based on the patient's testimony
No experience of tragic event in the last 6 months, based on the patient's testimony
Having a smartphone and messenger software and the ability to work with it
Living with spouse
Ability to read and write in Farsi
Iranian Nationality
Exclusion criteria:
Attend any previous counseling sessions
History of infertility
History of repeated abortion
Suffering from any physical or mental illnesses predisposing to abortion
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method was done using the website https://www.sealedenvelope.com, so that the samples are identified by block randomization method with 4 blocks and using random numbers table of under the web (online randomization). The control group was randomly assigned with the letter A and the intervention group with the letter B.
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 Iran University of Medical Sciences
Street address
No. 1, 2 Hades Alley, East 4th St, Eram Boul, Mehrshahr
City
Karaj
Province
Tehran
Postal code
3186754384
Approval date
2020-11-08, 1399/08/18
Ethics committee reference number
IR.IUMS.REC.1399.742
Health conditions studied
1
Description of health condition studied
Abortion
ICD-10 code
O03
ICD-10 code description
Spontaneous abortion
Primary outcomes
1
Description
Coping strategies
Timepoint
During 72 hours after abortion up to 3 months after abortion
Method of measurement
Coping Inventory questionnaire
2
Description
Self-efficacy
Timepoint
During 72 hours after abortion up to 3 months after abortion
Method of measurement
Schwartzer General Self-efficacy Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Self-efficacy and coping strategies questionnaires will be administered to patients within 72 hours after first abortion and then they will undergo midwifery counseling by Gamble's method. Gamble counseling strategy includes: Therapeutic connection between midwife and woman,accept and work with women’s perceptions,support the expression of feelings, filling in the missing pieces,connect the event with emotions and behaviors,review the abortion management,enhance social support,Reinforce positive approaches to coping and explore solutions. Intervention group undergo counseling in two 45-75 minutes sessions.The first session is done in person during the first 72 hours and the second session is done by phone 4-6 weeks after the abortion. After one month, patients will undergo counseling by telephone and will fill the self-efficacy and coping strategies questionnaires through online platforms. These questionnaires will be filled again two months after the second counseling session for the third time, through online platforms. Patients in intervention group will receive educations upon breast examination and necessity of pap smear test within 72 hours, one month and three months after the first abortion.
Category
Other
2
Description
Control group: Patients in control group will receive educations upon breast examination and necessity of pap smear test within 72 hours, one month and three months after the first abortion.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Kamali Hospital
Full name of responsible person
Masoume Kheirkhah
Street address
Kheyabane Shahid Yasmi
City
Tehran
Province
Tehran
Postal code
3186754384
Phone
+98 26 3330 8904
Email
Hasanzadefarzaneh1990@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Masoume Kheirkhah
Street address
Mehrshahr
City
Karaj
Province
Alborz
Postal code
3186754384
Phone
+98 26 3330 8904
Email
Hasanzadefarzaneh1990@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Information about the main outcome is shared
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Researchers, midwives, doctors
Under which criteria data/document could be used
Documentary researchers can be used for scientific advancement.
It is possible to access the data by sending an email to the supervisor.
Email: Shivakheirkhah1345@gmail.com
From where data/document is obtainable
Scientific party of the study
Masoumeh Kheirkhah
Email:Shivakheirkhah1345@gmail.com
Mobile:09124787691
What processes are involved for a request to access data/document
After approval by the research assistant by email to the supervisor
Email:Shivakheirkhah1345@gmail.com