Protocol summary

Summary
Most primiparous women don’t have enough sense of competency, most of it being due to lack of experience. Mindfulness Based Cognitive Therapy based training, have led to improved Maternal-infant outcomes. The purpose of this study was the efficacy of Mindfulness Based Cognitive Therapy Education on Maternal Role Attainment in Primiparous women. This clinical trial study with pretest-posttest and follow-up (1month) was conducted from 2015-2016. The population has formed primiparous mothers with an interval of 2 months and 2 years postpartum. Among them, 40 patients were selected that being single, age range 35-18 years, interval of 2 months and 2 years postpartum and gain the average and poor scores of maternal role attainment questionnaire. They assigned randomly in both experimental (20 person) and control (20 person) groups. Then, the experimental group received 8 sessions of MBCT (one session a week during 2 hours). The subjects in both groups completed the Maternal Role Inventory before and after intervention in MBCT group. Follow-up assessments of all participants occurred one month later. Data were analyzed using Chi-squre and Repeated Measure in SPSS software. The results of the present study indicated a significant difference between the control and experimental groups (P < 0.001); the mean scores of the MBCT group showed a significant increase compared to the control group.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016061328425N1
Registration date: 2016-08-14, 1395/05/24
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-08-14, 1395/05/24
Registrant information
Name
Seyed Zohre Sajadian
Name of organization / entity
Ahvaz Jundishapour University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 4347 4392
Email address
sajadian.z@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapour University of Medical Sciences
Expected recruitment start date
2015-08-06, 1394/05/15
Expected recruitment end date
2015-09-11, 1394/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Mindfulness on Maternal Role Attainment on Primiparous women
Public title
The effect of Mindfulness on Maternal Role Attainment
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Primiparous; single of fetus; Age range 35-18 year; The ability to read and write; spent at least 60 days and a maximum of 12 months from delivery; Availability in over the next 6 months; Scale score of less than 66 roles of mother Exclusion criteria: Failure to attend two sessions; refusal to continue cooperating with the investigation for any reason and at any stage of the investigation; The occurrence of abnormal stress caused by life events such as death of a spouse, divorce, violence and imprisonment wife; Having a physical and psychological disease identified; Addiction to alcohol; drugs and other psychotropic drugs.
Age
From 17 years old to 34 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ahvaz Jundishapour University of Medical Sciences
Street address
School of Nursing and Midwifery, Ahvaz Jundishapour University of Medical Science, Golestan highway
City
Ahvaz
Postal code
Approval date
2015-07-25, 1394/05/03
Ethics committee reference number
IR.AJUMS.REC.1394.272

Health conditions studied

1

Description of health condition studied
Disorder in Maternal Role Attainment
ICD-10 code
O90.9
ICD-10 code description
Complication of the puerperium, unspecified

Primary outcomes

1

Description
Maternal Role Attainment
Timepoint
Before, After Intervention, one and two month after intervention
Method of measurement
Maternal Role Attainment Questionnaire

Secondary outcomes

1

Description
Support and Strengthening of married couples relations
Timepoint
Before, After intervention, one and two month after intervention
Method of measurement
Maternal Role Attainment Questionnaire

2

Description
Difficulty and Dissatisfaction
Timepoint
Before, After Intervention. one and two after Intervention
Method of measurement
Maternal Role Attainment Questionnaire

3

Description
Attachment to child
Timepoint
Before, After Intervention, one and two after Intervention
Method of measurement
Maternal Role Attainment Questionnaire

4

Description
Concern and Anxiety
Timepoint
Before, After Intervention. one and two after Intervention
Method of measurement
Maternal Role Attainment Questionnaire

5

Description
Emotional Development
Timepoint
Before,After Intervention. ane and two month after intervention
Method of measurement
Maternal Role Attainment Questionnaire

6

Description
Function
Timepoint
Before,After Intervention. ane and two month after intervention
Method of measurement
Maternal Role Attainment

7

Description
Adaption and Social Development
Timepoint
Before, After Intervention, one and two month after in
Method of measurement
Maternal Role Attainment Questionnaire

Intervention groups

1

Description
The control group not recevied any intervention
Category
Behavior

2

Description
The intervention group received 8 sessions of 2 hours mindfulness training that will be formed once a week.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
17 Shahrivar Health Center
Full name of responsible person
Seyede Zohre Sajadian
Street address
East Health Center, Fifth alley, Aghayi street, Ahvaz
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz Jundishapour University of Medical Sciences
Full name of responsible person
Nahid Javadifar
Street address
School of Nursing and Midwifery, Ahvaz Jundishapour University of Medical Sciences, Golestan highway, Ahvaz
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapour University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Ahvaz Jundishapour University of Medical Sciences
Full name of responsible person
Seyede Zohre Sajadian
Position
Master of Science student of Counseling in Midwifery
Other areas of specialty/work
Street address
No 65, Bahar Alley, Shahid Dastgheyb Street, Marvdasht, Shiraz
City
Shiraz
Postal code
73771-38433
Phone
+98 71 4347 4392
Fax
Email
sajadianjz@gmail.comzohresajadian95@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapour University of Medical Science
Full name of responsible person
Seyede Zohre Sajadian
Position
Master of Science Student of Counseling in Midwifery
Other areas of specialty/work
Street address
No 65, Bahar Alley, Shahid Dastgheyb Street, Marvdasht, Shiraz
City
Shiraz
Postal code
7377138433
Phone
+98 71 4347 4392
Fax
Email
sajadianjz@gmail.comzohresajadian95@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapour University of Medical Sciences
Full name of responsible person
Seyede Zohre Sajadian
Position
Master of Science Student of Counseling in Midwifery
Other areas of specialty/work
Street address
No 65, Bahar Alley, Shahid Dastgheyb Street, Marvdasht, Shiraz
City
Shiraz
Postal code
7377138433
Phone
+98 71 4347 4392
Fax
Email
sajadianjz@gmail.com.....zohresajadian95@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...