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Investigating the effectiveness of mindful-self compassion program on distress tolerance, emotion regulation, mindfulness and quality of life in high risk pregnant women

Protocol summary

Study aim
Investigating the effectiveness of mindful-self compassion program on distress tolerance, emotion regulation, mindfulness and quality of life in high risk pregnant women
Design
A clinical trial, single-blind, randomized clinical trial on 52 high-risk pregnant women.
Settings and conduct
At first, written consent is obtained from high-risk pregnant women referring to Hospital, and necessary explanations are given regarding the current research (number of sessions, length of each session), confidentiality of information and the right to withdraw from the research at any time. In the current research, randomization and blinding will be done. Then, among the high-risk pregnant women referred to the hospital who have been diagnosed by obstetricians, 52 people will be randomly selected and 26 people will be randomly placed in each group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Gynecologist's diagnosis of high-risk pregnancy (pregnancies under 18 and over 40, history of frequent abortions, suspected premature birth, etc.) Not undergoing psychotherapy currently or in the past 6 months exclusion criteria:
Intervention groups
Intervention group: Consists of 26 high-risk pregnant women who, after completing the therapeutic intervention research questionnaires, will participate in 8 sessions held once a week for 1 hour. After completing the therapy sessions, participants will be provided with the research questionnaires again for completion. Control group: Consists of 26 high-risk pregnant women who will receive the research questionnaires in two stages without undergoing any therapeutic intervention.
Main outcome variables
distress tolerance; emotion regulation; mindfulness; Quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230713058767N1
Registration date: 2023-11-05, 1402/08/14
Registration timing: registered_while_recruiting

Last update: 2023-11-05, 1402/08/14
Update count: 0
Registration date
2023-11-05, 1402/08/14
Registrant information
Name
Mahsa Abdollahpur Kahriz
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2303 1548
Email address
m.abdollahpur1373@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-22, 1402/04/31
Expected recruitment end date
2024-01-19, 1402/10/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of mindful-self compassion program on distress tolerance, emotion regulation, mindfulness and quality of life in high risk pregnant women
Public title
Investigating the effectiveness of mindful-self compassion program in high risk pregnant women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Gynecologist's diagnosis of high-risk pregnancy (Pregnancies under the age of 18 and over 40, A history of repeated miscarriages, Suspected premature birth, diabetes, etc) Not undergoing psychotherapy now or in the last 6 months
Exclusion criteria:
Non-pregnant women Having certain physical diseases such as cancer Foreign nationals (non-Iranians)
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 52
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be simple randomization method. the random unit is individuals. 52 high risk pregnant will be divided into intervention and control groups by Microsoft Excel software using Rand function. in this way, a table of random numbers will be prepared and the Randbetween function will be created and the high risk will be divided into two groups of 26 people respectively.
Blinding (investigator's opinion)
Single blinded
Blinding description
In the current research, only the statistical analyst will not be involved in the type of intervention.
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Department of Clinical Psychology, Yas building, 4th floor, Ayatollah Taleghani Hospital, Arabi street, velenjak street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2023-07-22, 1402/04/31
Ethics committee reference number
IR.SBMU.MSP.REC.1402.182

Health conditions studied

1

Description of health condition studied
High risk pregnant
ICD-10 code
Z35.2
ICD-10 code description
Supervision of pregnancy with other poor reproductive or obstetric history

Primary outcomes

1

Description
Distress tolerance Being able to handle difficult emotions can help a person more quickly return to a state of equilibrium when new stressors arise.
Timepoint
The duration of the intervention is 8 sessions and one session per week, which lasts approximately 2 months.
Method of measurement
Simmons and Gaher Distress Tolerance Questionnaire

2

Description
Emotion regulation is a term generally used to describe a person's ability to effectively manage and respond to an emotional experience.
Timepoint
The duration of the intervention is 8 sessions and one session per week, which lasts approximately 2 months.
Method of measurement
Gertz and Romer emotion regulation questionnaire

3

Description
Mindfulness is a type of meditation in which you focus on being intensely aware of what you're sensing and feeling in the moment, without interpretation or judgment.
Timepoint
The duration of the intervention is 8 sessions and one session per week, which lasts approximately 2 months.
Method of measurement
Baer's five-facet questionnaire of self-awareness

4

Description
Quality of life as an individual's perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns.
Timepoint
The duration of the intervention is 8 sessions and one session per week, which lasts approximately 2 months.
Method of measurement
ٌWares Quality of life short form questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Mindful self compassion: education will be 8 sessions in 8 weeks for 2 groups. Each session lasts 45-60 minutes. mindful self compassion therapy includes two parts: mindfulness techniques to reduce rumination and worries about the future, and self-compassion, which includes techniques for behaving and speaking kindly to yourself.
Category
Treatment - Other

2

Description
Control group: High-risk pregnant women without intervention
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Mahdia Gynecology and Obstetrics Hospital
Full name of responsible person
Afshin Zarghi
Street address
Department of Clinical Psychology, Yas building, 4th floor, Ayatollah Taleghani Hospital, Arabi street, Velenjak street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2387 2505
Email
m.abdollahpur1373@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Department of Clinical Psychology, Yas building, 4th floor, Ayatollah Taleghani Hospital, Arabi street, Velenjak street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9783
Email
m.abdollahpur1373@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
50
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Position
PHD student
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Department of Clinical Psychology, Yas building, 4th floor, Ayatollah Al-Ghani Hospital, Arabi street, Velenjak street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
22439783
Email
m.abdollahpur1373@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Kristin Neff and Dr Christopher Germer
Position
PHD student
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Department of Clinical Pschology, Yas building, Ayatollah Taleghani Hospital, Arabi street, velenjak street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9783
Email
m.abdollahpur1373@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Kristin Neff and Dr Christopher Germer
Position
PHD student
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Department of Clinical Pschology, Yas building, Ayatollah Taleghani Hospital, Arabi street, velenjak street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9783
Email
m.abdollahpur1373@gmail.com

Sharing plan

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
Yes - There is 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
Yes - There is a plan to make this available
Title and more details about the data/document
In the current study, except for the confidential information of the clients, including the name and surname, all information including age, occupation, education, language, and social and economic status will be shared.
When the data will become available and for how long
The time to access information and data will be one week after the results are published.
To whom data/document is available
The results of the present study can be available to all people, including workers and researchers in this field and even other fields and the general public.
Under which criteria data/document could be used
Researchers and workers in this and other fields can access the results of this study without any restrictions.
From where data/document is obtainable
To access the results of this study, they can refer to the following website. m.abdollahpur1373@gmail.com
What processes are involved for a request to access data/document
After the publish of the results of this study, all the results will be available to the requestors of the results without any time limit.
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