The effect of mindfulness-based counseling on childbirth experience and support and control among nullipar women: a randomised controlled clinical trial
The effect of mindfulness-based counseling on experience, support and control of childbirth
Design
A clinical trial study on 64 primiparous mothers (32 in the intervention group and 32 in the control group) using RAS (Random Allocation Software) software with a size of four or six blocks and an allocation ratio of 1 : 1 will be divided into two groups receiving counseling and control group.
Settings and conduct
The research environment will be Taleghani and Al-Zahra teaching hospitals. Before the intervention and 24 hours after delivery, the participants will complete the questionnaires of delivery experience, support and control, and pain delivery.
Participants/Inclusion and exclusion criteria
Inclusion criteria: first delivery؛live fetus؛ cephalic singleton؛ tendency to give birth in Al-Zahra and Taleghani hospitals؛lack of mental disability and deafness. Inclusion criteria: history of pre-pregnancy mental disorders according to the patient؛ abnormal volume of amniotic fluid؛ nst non-reactıve؛Fetal abnormalities؛ Have any surgery on the uterus؛ Have a high-risk pregnancy؛ Pregnancy with the help of assisted reproductive techniques؛
Intervention groups
Intervention group: Receiving a counseling program with a mindfulness approach will be done in 8 45-minute group sessions. Control group: Routine care training in pregnancy will be held as a session every week online and in person.
Main outcome variables
Childbirth experience score, support and control score, labor pain score, labor fear score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171007036615N9
Registration date:2022-03-16, 1400/12/25
Registration timing:registered_while_recruiting
Last update:2022-03-16, 1400/12/25
Update count:0
Registration date
2022-03-16, 1400/12/25
Registrant information
Name
عصمت مهرابی
Name of organization / entity
دانشگاه علوم پزشکی تبریز
Country
Iran (Islamic Republic of)
Phone
+98 41 3477 0649
Email address
mehrabie@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-07, 1400/11/18
Expected recruitment end date
2022-04-07, 1401/01/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of mindfulness-based counseling on childbirth experience and support and control among nullipar women: a randomised controlled clinical trial
Public title
The effect of mindfulness-based counseling on nulliparous women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The first delivery
Live cephalic single fetus
Tendency to give birth in Al-Zahra and Taleghani hospitals
Lack of mental disability and deafness
Exclusion criteria:
1. History of pre-pregnancy mental disorders according to the patient3. 4. 5. 6. 7. 8. 9. 10.
Abnormal volume of amniotic fluid
NST non-reactive
Fetal malformations
Have any surgery on the uterus
Having high-risk pregnancies such as hypertension, diabetes, placenta previa, cardiovascular disease and other chronic diseases, bleeding in the third trimester, placental abruption, placenta previa, fetal growth disorder
Pregnancy with the help of assisted reproductive techniques
The desire to receive other pharmacological and non-pharmacological analgesics
Unplanned pregnancy
Any contraindications for vaginal delivery, including pelvic series mismatch
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
Participants using the RAS(Random Allocation Software)with the size of 4 and 6 blocks and quotas based on the type of labor pain onset (spontaneous or induction) and with a ratio of 1: 1 to the two groups receiving mindfulness counseling and allocation control group Will be given. Blocking was performed by a person not involved in sampling and data analysis. For concealment, the intervention type assignment will be written on a piece of paper and placed in matte envelopes and numbered in a row. These envelopes will be opened in the presence of the mother and by a person not involved in sampling (in charge of the hospital clinic) and the type of group will be informed to the mother.
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 Tabriz University of Medical Sciences
Street address
Tabriz college of Nursing and Midwifery, South Shariati St., Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Approval date
2022-02-06, 1400/11/17
Ethics committee reference number
IR.TBZMED.REC.1400.1121
Health conditions studied
1
Description of health condition studied
childbirth experience and support and control
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Childbirth experience score
Timepoint
24 hours after delivery
Method of measurement
Denker Childbirth Experience Questionnaire
2
Description
Support and control score
Timepoint
Before intervention and 24 hours after delivery
Method of measurement
Support and control questionnaire
Secondary outcomes
1
Description
Pain perception score
Timepoint
Dilatation at 6 cm and 24 hours after delivery
Method of measurement
Childbirth pain questionnaire Visual Analog Scale
2
Description
Fear of childbirth score
Timepoint
Dilatation at 6 cm and 24 hours after delivery
Method of measurement
Fear of childbirth in the labor stage will be using the WDE-Q (A) questionnaire and in the postpartum stage with the WDE-Q (B) fear of childbirth questionnaire.
Intervention groups
1
Description
Intervention group: Pregnant mothers who are in the mindfulness group, for 8 sessions of counseling program with the content of mindfulness as walking: walking slowly and intentionally and paying attention to movements, weight changes and balance and sensations in the legs that are related to walking. The process of eating: continues by feeling the raisins in the mouth, biting them, paying attention to the taste and texture, and the sensations and movements of the mouth and throat while chewing and swallowing the raisins. Awareness is done. Body scan: When lying on your back for 40 minutes, your attention is directed to different parts of your body (from toes to head) and you pay attention to the emotions in every part of your body with openness and curiosity.Sitting meditation: In a sitting position, the person is asked to pay attention to the feelings and movements of breathing. The person is instructed to pay attention to bodily feelings without judgment and acceptance. Yoga: Slow and gradual yoga Hatha Consciously nurtures the body when moving, stretching or maintaining a posture. Enters the body slowly and deeply into a dome-shaped body and abdomen, and then exhale very slowly without any pressure or contraction. It will be a minute.The assignments requested from the mothers in cyberspace will be reviewed by the researcher and the mother will be given feedback. Finally, after hospitalization and stabilization in the delivery room for each of the women in the mindfulness group, she will be reminded of the trainings of mindfulness techniques and in order to perform the steps of mindfulness correctly during labor and dilation of six centimeters ( Active phase of labor) will guide.
Category
Behavior
2
Description
Control group:. For the control group of routine care training (Trainings based on the educational content of physiological delivery, including nutritional, health, exercise and information's about physiological delivery and pain relief delivery methods) in pregnancy will be held as a session every week online and in person.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani
Full name of responsible person
Bahareh Sharegi
Street address
Taleghani Hospital،Railway Square، Tabriz، East Azerbaijan
City
Tabriz
Province
East Azarbaijan
Postal code
5351853871
Phone
+98 41 3442 4423
Email
iro@tbzmed.ac.ir
2
Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Bahareh Sharegi
Street address
Al-Zahra Educational and Medical Center, Baghshamal Intersection, South Army Street ،Tabriz،East Azarbaijan
City
Tabriz
Province
East Azarbaijan
Postal code
5143814998
Phone
+98 41 3553 9161
Fax
+98 41 3556 6449
Email
iro@tbzmed.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Parviz Shahabi
Street address
Vice Chancellor for Technology Research, Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Fax
+98 41 1334 4280
Email
permaosku2013@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Esmat Mehrabi
Position
Ph.D in reproductive health
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Fax
+98 41 3475 3906
Email
b.mehrabi@yahoo.com
Web page address
http://nursing.tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Esmat Mehrabi
Position
Ph.D in reproductive health
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
b.mehrabi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Esmat Mehrabi
Position
Ph.D in reproductive health
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Facuity of Nursing and Midwifery,South Shariati street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
b.mehrabi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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