Determination of self-hypnosis effect on fear and pain of normal delivery in primiparous women
Design
Controlled clinical trial, with a parallel group, randomized by blocking method with sample size of 70 patients.
Settings and conduct
The present clinical trial will be done in Ommolbanin hospital in Mashhad. After taking a written informed consent, persons will be placed in 2 groups based on random allocation with blocked method. The control group will receive only routine prenatal cares. Intervention group receive mentioned intervention in addition prenatal cares. Self-hypnosis education is done by researcher. Fear of childbirth will be measured before self-hypnosis education in 37th week of pregnancy, after ending two training self-hypnosis education sessions and cervix dilatation: 8-10 cm by Wijma Delivery Expectancy/Experience Questionnaire A and Delivery Fear Scale. Also pain of delivery will be measured by visual scale of pain (VAS).
Participants/Inclusion and exclusion criteria
Age:18-35 years old; Primiparous; Gestational age: 36-37 weeks; Not having depression, anxiety, stress; Having average and high level of hypnotic susceptibility; Having average and high level of fear of childbirth.
Intervention groups
The Intervention group will receive two training sessions of 15-20 minutes self-hypnosis education in 37-38th weeks of pregnancy in addition to usual prenatal cares. Audio file (15-20 minutes) of pain and fear control dialogues derived from sessions will be recorded by mother’s mobile phone and will be given to the pregnant woman in which listening and practicing self-hypnosis twice a day at home (morning and afternoon) until delivery time and then doing it at delivery.
Main outcome variables
Assessment fear of childbirth after self-hypnosis education in 38 week
Assessment fear of childbirth in active phase of labor.
Assessment of labor pain scale in active phase of labor.
General information
Reason for update
Acronym
SHFP
IRCT registration information
IRCT registration number:IRCT20190129042538N1
Registration date:2019-10-22, 1398/07/30
Registration timing:registered_while_recruiting
Last update:2019-10-22, 1398/07/30
Update count:0
Registration date
2019-10-22, 1398/07/30
Registrant information
Name
Batool Kamalimanesh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3841 2081
Email address
kamalimaneshb961@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-22, 1398/03/01
Expected recruitment end date
2019-12-21, 1398/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of self-hypnosis effect on fear and pain of normal delivery in primiparous women
Public title
Effect of self-hypnosis on fear and pain of normal delivery
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age: 36-37 weeks
Willingness to have a normal delivery
Having moderate to high degree of hypnotic susceptibility
Exclusion criteria:
Having high risk pregnancy
Having psychological disorders including depression, anxiety, stress
Having clinical fear (scoring greater than 85 points according to Wijma Expectancy/Experience Delivery Questioner type A)
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Study samples were divided into intervention and control groups by using Microsoft Excel computer program. The samples categorized into A and B groups.In this study, we used from quadruple blocks. All of quadruple blocks listed as AABB, ABBA, ABAB, BBAA, BAAB, BABA, and numbered from 1 to 6. Then randomly will be generated all of the numbers 1 through 6 and allocated them to the nominated blocks accordingly and then put them together.
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
Ethic committtee of Mashhad University of Medical Sciences
Street address
Ibne Sina Street, Crossroads Doctora, School of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2019-03-05, 1397/12/14
Ethics committee reference number
IR.MUMS.NURSE.REC.1398.005
Health conditions studied
1
Description of health condition studied
Fear of Childbirth
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Pain of Labour
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Score fear of childbirth (The Wijma Delivery Expectancy/Experience questionnaire A and Delivery Fear Scale)
Timepoint
Before training self-hypnosis in 37 week and after training self-hypnosis in 38 week by The Wijma Delivery Expectancy/Experience Questionnaire A, Evaluation fear of childbirth by Delivery fear scale in Cervical dilation 8-10 cm
Method of measurement
The Wijma Delivery Expectancy/Experience Questionnaire A, Delivery fear scale
2
Description
Pain of Labour
Timepoint
Cervical dilation: 8-10 cm
Method of measurement
Visual Analog Scale
Secondary outcomes
1
Description
Fear of childbirth
Timepoint
Two hours after delivery
Method of measurement
The Wijma Delivery Expectancy/Experience Questionnaire B
2
Description
Pain of labour
Timepoint
Cervical dilation: 4-5 cm
Method of measurement
Visual Analog Scale
3
Description
Childbirth Satisfaction
Timepoint
Two hours after delivery
Method of measurement
Mackey Childbirth Satisfaction Rating Scale
Intervention groups
1
Description
Intervention group will receive two training sessions of 15-20 minutes self-hypnosis education in 37-38th weeks of pregnancy in addition to usual prenatal cares. Audio file (15-20 minutes) of pain and fear control dialogues derived from sessions will be recorded by mother’s mobile phone and will be given to the pregnant woman in which listening and practicing self-hypnosis twice a day at home (morning and afternoon) until delivery time and then doing it at delivery.
Category
Other
2
Description
Control group received routine prenatal care.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ommolbanin hospital
Full name of responsible person
Fatemeh Tara
Street address
Ayatolah Bahjat Street, Mashhad, Khorasan
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3223 1061
Fax
+98 51 3223 1444
Email
p.relations@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Saeid Eslami
Street address
Daneshgah Str.
City
Mashhad
Province
Razavi Khorasan
Postal code
1394491388
Phone
+98 51 3841 2081
Fax
+98 51 3841 3006
Email
Presidentoffice@mums.ac.ir
Web page address
http://www.mums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Batool Kamalimanesh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Daneshgah str.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Fax
+98 51 3841 3006
Email
Kamalimaneshb961@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Maryam Moradi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Daneshgah str.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Fax
+98 51 3841 3006
Email
Moradim@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Batool Kamalimanesh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Daneshgah Str.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
B.kamalimanesh@gmail.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