Protocol summary

Study aim
Determining the effectiveness of treatment based on acceptance and commitment on perceived stress, psychological toughness, emotional regulation of nurses
Design
Two groups of subjects, including an experimental group and a control group with 20 people for each group, both experimental and control groups, are measured twice (pre-test-post-test) by questionnaires. Clinical trial with control group, blinded, randomized and without study phase on 40 nurses
Settings and conduct
The experimental groups will be treated with Act; But the control group does not receive any intervention. Both the experimental group and the control group are measured twice (pre-test-post-test) separately. The statistical population will be all the nurses of the gynecological department of public hospitals in Semnan city. It will be implemented virtually on the Literary platform of Connect, and every week two to three intervention sessions and one introduction session will be held face-to-face with the nurses of the sample group before the implementation of the research.
Participants/Inclusion and exclusion criteria
The age of the participants should be between 25 and 50 years old and they should not have completed the ACT treatment course and should not have an acute or chronic physical or mental illness that disrupts the work process.
Intervention groups
including 40 nurses (20 in both experimental and control groups) Then, people will be assigned in two experimental and control groups by simple random sampling method.
Main outcome variables
Acceptance and commitment therapy: independent distance Perceived stress: a continuous interval Psychological hardiness: a distance variable Emotion regulation: continuous interval

General information

Reason for update
Acronym
Act
IRCT registration information
IRCT registration number: IRCT20220707055405N1
Registration date: 2022-08-10, 1401/05/19
Registration timing: registered_while_recruiting

Last update: 2022-08-10, 1401/05/19
Update count: 0
Registration date
2022-08-10, 1401/05/19
Registrant information
Name
Niusha Rastegar kafshgari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 4225 9899
Email address
rastegarniusha@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-01, 1401/05/10
Expected recruitment end date
2022-09-01, 1401/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of Acceptance and Commitment Therapy (ACT) on Perceived stress , Psychological Hardiness and Emotional Regulation in nurses
Public title
The effectiveness of Acceptance and Commitment Therapy on Perceived stress , Psychological Hardiness and Emotional Regulation in nurses
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
nurses should work in public hospitals in semnan their age should be between 25 and 50
Exclusion criteria:
Failure to complete the course of treatment based on acceptance and commitment
Age
From 25 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 40 people are selected according to similar research, in the available way. Then random replacement is done by lottery method (one number will be assigned to each of the sampled people). We write down the numbers on paper, fold them and put them in a container. We mix and stir the papers completely. Then we take out the papers one by one and put one number in the first group and one number in the second group. Then random application will be done. In this way, one group is known as "control group" and the other group is known as "intervention group". The lottery will be done by putting the two groups obtained from the previous step (random replacement step) into two separate envelopes and placing them in a container. Then we randomly take one envelope out of the container and assign it to the "intervention group" and the other envelope to the "control group". Research data are analyzed using SPSS version 21 statistical package software in social sciences Simple randomization
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University, Semnan branch
Street address
University campus, Islamic Azad University, Semnan branch
City
Semnan
Province
Semnan
Postal code
3513137111
Approval date
2022-07-27, 1401/05/05
Ethics committee reference number
IR.IAU.SEMNAN.REC.1401.024

Health conditions studied

1

Description of health condition studied
The effectiveness of Acceptance and commitment therapy on perceived stress, psychological hardiness and emotional regulation in nurses
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
"Determining the effectiveness of treatment based on acceptance and commitment on perceived stress" depression score in Cohen's perceived stress questionnaire
Timepoint
The first measurement is by performing a pre-test at the beginning of the study and the second measurement is by performing a post-test after the study
Method of measurement
Cohen's Perceived Stress Questionnaire (1983)

2

Description
"Determining the effectiveness of treatment based on acceptance and commitment on the psychological toughness of nurses" psychological toughness score in Kubasa psychological toughness questionnaire
Timepoint
The first measurement is by performing a pre-test at the beginning of the study and the second measurement is by performing a post-test after the study
Method of measurement
Kubasa Psychological Toughness Questionnaire (1979)

3

Description
"Determining the effectiveness of treatment based on acceptance and commitment on the emotional regulation of nurses" emotional regulation score in Garnevsky's emotional regulation questionnaire
Timepoint
The first measurement is by performing a pre-test at the beginning of the study and the second measurement is by performing a post-test after the study
Method of measurement
Garnevsky emotion regulation questionnaire (2001)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: an educational-therapeutic course that includes 8 treatment sessions and two to three sessions a week, each session lasting one and a half hours on the subjects of the experimental group based on a certain schedule in the sessions determined according to the package headings. Treatment training is based on acceptance and commitment
Category
Treatment - Other

2

Description
Control group: It does not receive any intervention
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shefa hospital
Full name of responsible person
Rastegarkafshgari Niusha
Street address
Semnan Province, Semnan, Shahid Noroozi Blvd, Shafa Hospital
City
Semnan
Province
Semnan
Postal code
3514895171
Phone
+98 23 3342 3312
Email
shefa.hos@tamin.ir

2

Recruitment center
Name of recruitment center
Amiralmomenin hospital
Full name of responsible person
Rastegarkafshgari Niusha
Street address
No 9771, Imam Hossein Square, Shahid Mostafa Khomeini Blvd
City
Semnan
Province
Semnan
Postal code
3473135197
Phone
+98 23 3346 0055
Email
amir.hospital@semums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Beidokhti hengame
Street address
University campus, Islamic Azad University, Semnan branch
City
Semnan
Province
Semnan
Postal code
3513137111
Phone
+98 23 3365 4040
Email
akram4453@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Rastegarkafshgari Niusha
Position
University student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Shahid Beheshti Street, 24 Adalat Alley, 2 Gholinejad Alley, Pasargad Building, 2nd floor
City
ghaemshahr
Province
Mazandaran
Postal code
4765876884
Phone
+98 11 4225 9899
Email
rastegarniusha@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Rastegarkafshgari Niusha
Position
University student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Shahid Beheshti Street, 24 Adalat Alley, 2 Gholinejad Alley, Pasargad Building, 2nd floor
City
Ghaemshahr
Province
Mazandaran
Postal code
4765876884
Phone
+98 11 4225 9899
Email
rastegarniusha@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Rastegarkafshgari Niusha
Position
University student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Shahid Beheshti Street, 24 Adalat Alley, 2 Gholinejad Alley, Pasargad Building, 2nd floor
City
Ghaemshahr
Province
Mazandaran
Postal code
4765876884
Phone
+98 11 4225 9899
Email
rastegarniusha@gmail.com

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
There is no further information
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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