1
Clinical Trial Protocol
Iranian Registry of Clinical Trials
05 Nov 2022
Effectiveness of Snoezelen Room on Fear,Anexiety and Satisfaction of Childbirth in Primiparous Women.
Protocol summary
Summary
The aim of this study is the effectiveness of Snoezelen rooms on primiparous women’s fear, anxiety, and satisfaction with their childbirth Method: The present study is a randomized clinical trial with 65 participants in the each group, snoezelen room for intervention and physiological delivery rooms as the control group.
Inclusion criteria: mother do not have physical or mental illnesses such as (migraine, epilepsy, asthma, allergies and currently pregnancy complication); fetus weight between 2500-3500 gram; no cephalo-pelvic disproportion; 37 weeks and over gestational age;
dilatation of 3-4 centimeters at the time of entering;
mothers’ age 18 to 35; no stressful events for mother during six months before; normal fetal heart rate.
Exclusion criteria: complications during labor that impair normal delivery process. Scale for primary outcomes are four questionnaires, demographic information, Hartman’s for fear of pregnancy, using VAS for anxiety, and
pregnancy satisfaction questionnaires. Fear and anxiety at entrance and during labor at four to eight centimeter of dilation for four times and again after birth,
satisfaction at fourth phase of childbearing (one hour) after delivery with stable mother's vital signs will be measured. The mean score of fear, anxiety and satisfaction will be accounted and compared between two groups. .
General information
Acronym
IRCT registration information
IRCT registration number: IRCT201312073034N13 Registration date: 2015-10-30, 1394/08/08 Registration timing: registered_while_recruiting
Last update:
Update count: 0
Registration date 2015-10-30, 1394/08/08 Registrant information
Name
Mansoureh Jamshidimanesh Name of organization / entity
Iran University Faculty of Nursing & Midwifery Country
Iran (Islamic Republic of) Phone
+98 21 4365 1811 Email address
delshad2@iums.ac.ir Recruitment status
Recruitment complete Funding source
Vice chancellor for research, school of Nursing and Midwifery, Iran University of Medical Scienc.
Expected recruitment start date 2015-10-07, 1394/07/15
Expected recruitment end date 2016-02-20, 1394/12/01 Actual recruitment start date
empty
Actual recruitment end date empty
Trial completion date empty
Scientific title
Effectiveness of Snoezelen Room on Fear,Anexiety and Satisfaction of Childbirth in Primiparous Women.
Public title
Effectiveness of Snoezelen Room on Fear,Anexiety and Satisfaction of Childbirth in Primiparous Women.
Purpose Supportive
Inclusion/Exclusion criteria
2 Inclusion criteria: mother do not have physical or mental
illnesses such as (migraine, epilepsy, asthma, allergies and currently pregnancy complication); fetus weight between 2500-3500 gram; no cephalo-pelvic disproportion; 37 weeks and over gestational age;
dilatation of 3-4 centimeters at the time of entering;
mothers’ age 18 to 35; no stressful events for mother during six months before; normal fetal heart rate.
Exclusion criteria: complications during labor that impair normal delivery process.
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: 130
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
Ethics committee Vice chancellor for Research Iran University of Medical Sciences
Street address
Vice chancellor for research Iran University of Medical Sciences
City Tehran Postal code Approval date
2015-07-15, 1394/04/24
Ethics committee reference number IR.IUMS.rec 1394.9211373209
Health conditions studied
1
Description of health condition studied
fear, anxiety, and satisfaction with their childbirth.
ICD-10 code 075.0
ICD-10 code description
Maternal distres during labor and delivery
Primary outcomes
1
Description
fear, anxiety and satisfaction of childbearing Timepoint
prior, four times during labor for fear and anxiety.
satisfaction one hour after delivery Method of measurement
questionnaires
Secondary outcomes
1
Description fear of childbirth Timepoint
Before birth and during the transitional phase Method of measurement
questionnaire
2
Description
anxiety of childbirth Timepoint
Before birth and during the transitional phase Method of measurement
questionnaire
3
Description
satisfaction of childbirth Timepoint
postpartum duration Method of measurement
questionnaire
Intervention groups
1
Description
in the control group questionnaire fear of childbirth and anxiety at the beginning of the 65 mothers will explore Physiological delivery room and then every 1 hour during the transitional phase of research will be to help
Satisfaction with partial recovery after the birth mother is completed.
Category Other
3
2
Description
in the intervention group questionnaire fear of childbirth and anxiety at the beginning of the 65 mothers will explore relaxation room and then every 1 hour during the transitional phase of research will be to help
Satisfaction with partial recovery after the birth mother is completed.
Category Other
Recruitment centers
1
Recruitment center
Name of recruitment center Akbar Abadia Hospital
Full name of responsible person Mansoureh Jamshidi Manesh Street address
Molavi Street City
Tehran
Sponsors / Funding sources
1
SponsorName of organization / entity
Vice chancellor for Research, School of Nursing and Midwifery, Iran University of Medical Scienc Full name of responsible person
Dr Frough Rafiea , Dr Ali Javad Mosavi Street address
Vice chancellor for research, school of Nursing and Midwifery, Iran University of Medical Scienc City
Tehran Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Research, School of Nursing and Midwifery, Iran University of Medical Scienc 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
Midwifery Department, School of Nursing and Midwifery, Iran University of Medical Scienc Full name of responsible person
Mansoureh Jamshidi Manesh Position
Reproductive Health Candidate Other areas of specialty/work Street address
Midwifery Department, School of Nursing and Midwifery, Iran University of Medical Scienc Yasami Ally, Valie Asr Avenu, Vanak SQ
City Tehran Postal code Phone
+98 912 259 1557 Fax
jamshidimanesh@yahoo.com Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nursing & Midwifery Faculty Iran University of Medical Sciences
Full name of responsible person Mansoureh Jamshidi Manesh Position
Reproductive Health Candidate Other areas of specialty/work Street address
Rashid Yassami Stree، Vali Asr Street Martyr،Tehran City
Tehran Postal code Phone
00 Fax Email
jamshidimanesh@yahoo.com Web page address
Person responsible for updating data
Contact
Name of organization / entity
Nursing & Midwifery Faculty University of Medical Sciences
Full name of responsible person Mansoureh Jamshidi Manesh Position
Nursing & Midwifery Faculty Shahrood University of Medical Sciences
Other areas of specialty/work Street address
4
Rashid Yassami Street،Vali Asr Street martyr،Tehran
CityTehran
Postal code Phone00
Fax Emailjamshidimanesh@yahoo.com
Web page addressSharing 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
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