Studying the impacts of the combination of effective methods compared with doula on reducing anxiety and pain of mothers in childbirth in the Jam Tohid Hospital in 2015
Objective: To compare the collective impact of effective methods on reducing anxiety and pain of mothers in childbirth with the effect of doula in the Jam Tohid hospital in 2015
Study Type: This is an interventional study will be conducted on two groups who will receive a combination of effective methods and those who only have doula. This study will be carried out in the Jam Tohid Hospital Affiliated to Bushehr University of Medical Sciences.
Inclusion criteria: Nulliparous pregnant women aged 16-44; Having a single fetus; Not having any pregnancy complications as well as mental diseases; At least 32 weeks of gestational age
Type of intervention and the time of intervention: The studied women will be allocated randomly to two groups: study group (the combination of effective methods) and control group (doula). During pregnancy, in coordination with the mother-friendly hospital heads, several pregnancy and childbirth preparation classes (6 sessions with about 105 minutes within a week of each other will be held by the by the researcher and his colleagues which are about training neuromuscular exercises, relaxation, proper breathing, concentration exercises and also the appropriate positions in childbirth.
Intervention outcomes: Reduced pain and anxiety of labor
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015083123837N1
Registration date:2015-10-26, 1394/08/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-10-26, 1394/08/04
Registrant information
Name
Ramin Ravangard
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 224 3772
Email address
ravangard@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2015-04-21, 1394/02/01
Expected recruitment end date
2015-07-23, 1394/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying the impacts of the combination of effective methods compared with doula on reducing anxiety and pain of mothers in childbirth in the Jam Tohid Hospital in 2015
Public title
Studying the impacts of the combination of effective methods compared with doula on reducing anxiety and pain of mothers in childbirth in the Jam Tohid Hospital in 2015
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion Criteria:
- Being Iranian;
- Age between 16 and 44;
- First pregnancy;
- At least 32 weeks of gestational age;
- Lack of pregnancy complications;
- Having a live fetus;
- Having a single fetus;
- Start spontaneous contractions;
- Intact sac;
- No pelvic restraint;
- No history of hospitalization due to complications of pregnancy;
- No history of diseases such as thyroid, and diseases related to the kidney, heart, liver, diabetes, and lack of psychiatric diseases.
Exclusion Criteria:
- Fetal macrosomia;
- The studied pregnant women's unwillingness to continue their cooperation with the researcher and participation in the intervention;
- Fetal anomaly detection during the study;
- Onset of labor before or after term;
- Fetal distress;
- Premature rupture of membranes;
- The use of pain relievers;
- The occurrence of any complications during labor and delivery and the need for cesarean section.
Age
From 16 years old to 44 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
150
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
The Ethics Committee in Biomedical Research, Shiraz University of Medical Sciences, Cose: EC UMS S I
Intervention: During pregnancy, in coordination with the mother-friendly hospital heads, several pregnancy and childbirth preparation classes (6 sessions with about 105 minutes within a week of each other will be held by the by the researcher and his colleagues which are about training neuromuscular exercises, relaxation, proper breathing, concentration exercises and also the appropriate positions in childbirth.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Tohid hospital in Jam
Full name of responsible person
Dr. Ravangard
Street address
Bushehr, Jam, Shahrak Tohid
City
Bushehr
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Seyed Basir Hashemi
Street address
Iran
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Ramin Ravangard
Position
Assistant Prof.
Other areas of specialty/work
Street address
Iran
City
Shiraz
Postal code
7134814336
Phone
+98 71 3234 0774
Fax
+98 71 3234 0039
Email
ravangard@sums.ac.ir; ra_ravangard@yahoo.com
Web page address
sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Ramin Ravangard
Position
Assistant Prof.
Other areas of specialty/work
Street address
Iran
City
Shiraz
Postal code
7134814336
Phone
+98 71 3234 0774
Fax
+98 71 3234 0039
Email
ravangard@sums.ac.ir; ra_ravangard@yahoo.com
Web page address
sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Ramin Ravangard
Position
Assistant Prof.
Other areas of specialty/work
Street address
Iran
City
Shiraz
Postal code
7134814336
Phone
+98 71 3224 0774
Fax
+98 71 3234 0039
Email
ravangard@sums.ac.ir; ra_ravangard@yahoo.com
Web page address
sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)