Labour pain and its management remains a primary concern for childbearing women, their families, and their health-care providers. Pharmaceutical and non-pharmaceutical ways be considered for labor pain relief. Many women approach childbirth with a desire to avoid pharmacologic pain relief agents or to minimise their use. Coping strategies can assist in the pain management process. Self-efficacy playing an important role in a woman’s ability to cope and indicated that self-efficacy affects childbirth experiences, both in terms of bodily functions and in thoughts and feelings regarding childbirth. If women are highly self-confident, they will be able to cope with childbirth, enjoying a positive childbirth experience. the birth ball has been shown to be a valuable and comfortable tool in clinical practice that have effects on coping ability. This study will be conducted to examine the effects of a birth ball exercise programme during childbirth in terms of childbirth self-efficacy and childbirth pain. Design: randomised controlled trial.
Methods: the study will conducted in 60 pregnant women who refere to Iajar birth center for prenatal care. participants will be allocated by block randomisation into the two arms of the study(intervention & control). Intervention group will receive the birth ball exercise programme consisted of a booklet and films, with periodic follow-ups during prenatal checks. Both the experimental and control groups received standard midwifery care.
Measurements: the women will complete demographic information, the Childbirth Self-efficacy Inventory (CBSEI), and the short form of the McGill Pain Questionnaire (SF-MPQ) in active phase of labor(cervical dilations four and eight centimetres) and at second stage of labor.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016120631238N2
Registration date:2017-03-08, 1395/12/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-03-08, 1395/12/18
Registrant information
Name
shahnaz Kohan
Name of organization / entity
Isfaha University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 3078
Email address
kohan@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2016-12-21, 1395/10/01
Expected recruitment end date
2017-02-19, 1395/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of birth ball exercise on labor pain and self-efficacy : A randomised controlled trial in Shahrekord
Public title
Birth ball effect on labor pain and self-efficacy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: (1) pregnant women aged between 18-35 years old (2)women are 30–32 weeks of gestation (3) had no major obstetric or medical pregnancy complications according to the maternal booklet (eg hypertention or anemia) (4) a singleton pregnancy (5) ability to undertake activities (6) the ability to speak, read, and write persian, (7) had no conterandiation for normal delivery like placenta previa.
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:
60
Randomization (investigator's opinion)
Randomized
Randomization description
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
Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar jarib
City
Isfahan
Postal code
Approval date
2016-09-22, 1395/07/01
Ethics committee reference number
IR.MUI.REC.1394.2.147
Health conditions studied
1
Description of health condition studied
Normal delivery
ICD-10 code
080
ICD-10 code description
Spontaneous vertex delivery
Primary outcomes
1
Description
Pain
Timepoint
In active phase of labor and second stage of labor
Method of measurement
Mcgill pain Standard questionnaire
Secondary outcomes
1
Description
Self efficacy
Timepoint
In active phase of labor and second stage of labor
Method of measurement
Lowe self-efficacy Standard questionnaire
Intervention groups
1
Description
The birth ball exercise programme for 6-8 weeks, consisted of a booklet and films, with periodic follow-ups for home exercise and routine orenatal cares
Category
Other
2
Description
Routine exercise prenatal care for control group
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hajar Hospital of Shahrekord
Full name of responsible person
Ziba Raeisi Dehkordi
Street address
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Mahdi Nematbakhsh
Street address
Isfahan University of Medical Sciences, Hezar Jarib
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Morvarid Ghasab Shirazi
Position
PhD Candidate Student Reproductive Health
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezar Jarib
City
Isfahan
Postal code
Phone
+98 31 3792 7533
Fax
Email
morvashirazi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Morvarid Ghasab Shirazi
Position
PhD Candidate Student Reproductive Health
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezar Jarib
City
Isfahan
Postal code
Phone
+98 31 3792 7533
Fax
Email
morvashirazi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan university of medical sciences
Full name of responsible person
shahnaz Kohan
Position
Assistant professor
Other areas of specialty/work
Street address
Hezar jarib
City
Isfahan
Postal code
Phone
+98 31 3792 7533
Fax
Email
kohan@nm.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)