Protocol summary

Study aim
Determining the effect of Acceptance and Commitment Therapy on feeling of inferiority and academic engagement of midwifery students of Zanjan university of medical science in 2023-2024
Design
A randomized controlled clinical trial with parallel groups involving 64 participants. (The table of random numbers will be used for randomization.)
Settings and conduct
Sampling will be done in Zanjan University of Medical Sciences. First, 64 eligible students will be randomly selected and then by the stratified block randomization (according to academic semester) assigned to the intervention and control groups. The intervention group will receive 8 sessions of 60-minute of group counseling. The participants will complete self-report questionnaires before the intervention, immediately after the intervention and one month after the last counseling session.
Participants/Inclusion and exclusion criteria
The research community includes all midwifery undergraduate students of Zanjan University of Medical Sciences in 2023-2024.
Intervention groups
The People of the intervention group will participate in 8 sessions of 60-minute (once a week) of group counseling based on Acceptance and Commitment Therapy, which will be provided by the researcher. People in the control group will not receive any intervention.
Main outcome variables
Inferiority feeling, Academic engagement

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160608028352N12
Registration date: 2023-11-21, 1402/08/30
Registration timing: prospective

Last update: 2023-11-21, 1402/08/30
Update count: 0
Registration date
2023-11-21, 1402/08/30
Registrant information
Name
Roghieh Kharaghani
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 3314 8144
Email address
r.kharaghani@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-21, 1402/09/30
Expected recruitment end date
2024-06-19, 1403/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of Acceptance and Commitment Therapy on feeling of inferiority and academic engagement of midwifery students of Zanjan university of medical science
Public title
The efficacy of Acceptance and Commitment Therapy on feeling of inferiority and academic engagement of midwifery students of Zanjan university of medical science
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Midwifery undergraduate students of Zanjan University of Medical Sciences Full consent to participate in the research Having physical and mental health (based on the participants' self-report form) Obtaining a higher than average score in the inferiority feeling questionnaire or a lower than average score in the academic engagement questionnaire
Exclusion criteria:
Failure to participate in the test after intervention and follow-up Absence in more than two sessions in training sessions Simultaneous participation in other psychotherapy programs Completion of questionnaires incompletely Unwillingness to continue cooperation Unforeseen events
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 64
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling method will be convenient and the allocation method will be stratified blocked randomization (according to academic semester). For this purpose, four people blocks have been created to determine the two groups of intervention and control. The sample size in two groups is 64 participants, so the allocation of participants in the intervention and control groups will be done by random selection of 16 blocks of four-person blocks. The table of random numbers will be used for randomization.
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
The ethics committee of Zanjan University of Medical Sciences
Street address
The ethics committee of Zanjan University of Medical Sciences, first floor, Northside of Azadi Boulevard, Zanjan.
City
Zanjan
Province
Zanjan
Postal code
4525613113
Approval date
2023-11-15, 1402/08/24
Ethics committee reference number
IR.ZUMS.REC.1402.197

Health conditions studied

1

Description of health condition studied
Health of students
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Inferiority feeling
Timepoint
Before the intervention, immediately after the intervention and one month after the last counseling session
Method of measurement
Inferiority Feeling Scale (Yao)

2

Description
Academic engagement
Timepoint
Before the intervention, immediately after the intervention and one month after the last counseling session
Method of measurement
Academic Engagement Scale (Schafeli)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The people of the intervention group will be given 8 sessions of 60 minutes (once a week) group counseling based on Acceptance and Commitment Therapy, which will be provided by the researcher. The participants of the intervention group will be divided into 2 groups of 10 and one group of 12. The researcher will be taught the content of sessions and counseling with the approach of acceptance and commitment in person by a psychologist consultant and also in the form of online or face-to-face workshops.
Category
Behavior

2

Description
Control group: Participants in this group will not receive any intervention.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Zanjan University of Medical Sciences
Full name of responsible person
Zahra Norouzi
Street address
Zanjan University of Medical Sciences, Gavazang Road.
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3314 8300
Email
zahranorouzi23178@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Samad Nedri
Street address
chancellor for Research and Technology of Zanjan University of Medical Sciences, first floor, Northside of Azadi Boulevard, Zanjan.
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3314 8300
Email
nadri_s@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Zahra Norouzi
Position
Master's student in counseling in midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Zanjan University of Medical Sciences, Gavazang Road.
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3314 8300
Email
zahranorouzi23178@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Roghieh Kharghani
Position
PhD of Reproductive Health
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Zanjan University of Medical Sciences, Gavazang Road.
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3314 8300
Email
r.kharaghani@zums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Zahra Norouzi
Position
Master's student in counseling in midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Zanjan University of Medical Sciences, Gavazang Road.
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3314 8300
Email
zahranorouzi23178@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
After completion of the study, information about the main outcome will be shared.
When the data will become available and for how long
Starting the access period from 2024
To whom data/document is available
Data and documentation will be available to medical researchers.
Under which criteria data/document could be used
The data can be used to study, give a citations, create new ideas and practically apply in educational centers.
From where data/document is obtainable
Email to zahranorouzi23178@gmail.com
What processes are involved for a request to access data/document
The data will be provided to the applicant within one month after reviewing and confirming the request.
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