Protocol summary

Study aim
To assess the effect of implementing a dignity-based maternity care program versus control group on fear of childbirth and childbirth satisfaction among mothers referring to the labor and delivery unit
Design
This is a single-blind randomized clinical trial with a control group with parallel groups, in which 62 eligible patients will be randomly assigned to the intervention and control groups using block randomization.
Settings and conduct
This study will be conducted at the Fatemieh Hospital in Hamadan, involving 62 eligible mothers referring to the labor and delivery unit. The patients will be randomly assigned to the intervention and control groups through the block randomization. This trial will be single-blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 18–45 years, Primiparity (first-time mother), Gestational age of 37–42 weeks, Planned vaginal delivery, Singleton pregnancy, Normal, low-risk pregnancy, Exclusion Criteria: History of miscarriage or stillbirth, History of infertility, Any chronic medical conditions, Psychiatric disorders, Birth of an infant with an Apgar score of less than 7 at 5 minutes
Intervention groups
Intervention group: Routine clinical care standard in the labor and delivery unit, supplemented by a "maternal dignity-based" care program—implemented from admission through discharge Control Group: Routine clinical care standard in the labor and delivery unit
Main outcome variables
Primary outcome: Fear of childbirth score, Maternal satisfaction score

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120215009014N628
Registration date: 2026-11-06, 1405/08/15
Registration timing: prospective

Last update: 2026-11-06, 1405/08/15
Update count: 0
Registration date
2026-11-06, 1405/08/15
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2026-12-01, 1405/09/10
Expected recruitment end date
2027-05-31, 1406/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of implementing a dignity-based maternity care program versus control group on fear of childbirth and childbirth satisfaction among mothers referring to the labor and delivery unit: a single-blind randomized clinical trial
Public title
Effect of implementing a dignity-based maternity care program versus control group on fear of childbirth and childbirth satisfaction among mothers referring to the labor and delivery unit
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18–45 years, Primiparity (first-time mother), Gestational age of 37–42 weeks, Planned vaginal delivery, Singleton pregnancy, Normal, low-risk pregnancy,
Exclusion criteria:
History of miscarriage or stillbirth, History of infertility, Any chronic medical conditions, Psychiatric disorders, Birth of an infant with an Apgar score of less than 7 at 5 minutes
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 62
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, random assignment of patients to the intervention and control groups will be carried out using block randomization. To achieve this, four sheets of paper will be prepared - two with the name of the intervention and two with the name of the control. These paper sheets will be pooled and placed in a container. Patients will be selected one at a time without replacement, and for each patient, a paper sheet will be randomly drawn from the container. After each draw, the paper sheets will be returned to the container, and the process will be repeated until the desired sample size is reached.
Blinding (investigator's opinion)
Single blinded
Blinding description
The randomization process will be conducted by a separate individual from the one who examines the patients, ensuring that the examining person remains unaware of the intervention. Therefore, the trial will be conducted as a single-blind study.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2026-10-31, 1405/08/09
Ethics committee reference number
IR.UMSHA.REC.1405.621

Health conditions studied

1

Description of health condition studied
Fear of childbirth
ICD-10 code
F40.232
ICD-10 code description
Fear of other medical care

Primary outcomes

1

Description
Fear of childbirth score
Timepoint
At the time of entry into the study and two hours postpartum
Method of measurement
Based on the Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ)

2

Description
Maternal satisfaction score regarding the childbirth experience
Timepoint
At the time of entry into the study and two hours postpartum
Method of measurement
Based on the Childbirth Experience Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Routine clinical care standard in the labor and delivery unit, supplemented by a "maternal dignity-based" care program—implemented from admission through discharge (consisting of four phases: 1) Admission (respectful treatment, privacy maintenance, provision of clear information, and obtaining informed consent); 2) During labor (continuous emotional support, maternal involvement in decision-making, provision of oral fluids—unless medically contraindicated—offering pain relief methods, and encouraging position changes while avoiding the supine position); 3) Birth phase (continuous support and encouragement to choose a suitable birthing position); and 4) Postpartum (providing information regarding the condition of the mother and newborn, skin-to-skin contact, support for early initiation of breastfeeding, and emotional support for the mother)
Category
Treatment - Other

2

Description
Control Group: Routine clinical care standard in the labor and delivery unit
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Fatemieh Hospital in Hamadan
Full name of responsible person
Zahra Karami
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3828 3939
Email
Zahrakarami7697@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Alireza Soltanian
Street address
Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Zahra Karami
Position
Midwifery Student
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
Zahrakarami7697@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Azita Tiznobeik
Position
Reproductive Health Specialist
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
Azita.tizno@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir

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
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