Protocol summary

Study aim
Comparative determination of the effect of squat and butterfly exercise on the intensity of pain and the length of labor stages in primiparous women
Design
This study is a randomized, single-center, three-group, parallel-group, open-label clinical trial that will be conducted on 84 primiparous women (28 women per group). Participant allocation will be done using a block randomization method and a sequence generated by Microsoft Excel software with an allocation ratio of 1:1:1.
Settings and conduct
Primiparous women who present to the delivery room of Iran Hospital, Iranshahr with labor pain and 3-4 cm dilation and meet the inclusion criteria will then be assigned to three groups of squats, butterfly movements, and control using a block random assignment method.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Primiparous women with a gestational age of 37 to 42 weeks and singletons who have full consent to participate in the study and are members of the Vertex Fetal Display. Exclusion criteria: Mother's withdrawal from participation in the study at any stage of the study, any factor that causes emergency cesarean section, use of vacuum, receiving any type of analgesia during the study, in the event of any abnormal changes in the fetal ECG or fetal distress during the study
Intervention groups
Three parallel groups will be conducted, including the Squat group, the Butterfly group, and the control group.
Main outcome variables
Reducing the intensity of pain and the length of labor

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20260619069866N1
Registration date: 2026-06-30, 1405/04/09
Registration timing: prospective

Last update: 2026-06-30, 1405/04/09
Update count: 0
Registration date
2026-06-30, 1405/04/09
Registrant information
Name
Mahtab Karimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3423 2175
Email address
mahtabkarimi7557@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-07-23, 1405/05/01
Expected recruitment end date
2026-09-23, 1405/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the effect of squats and butterfly movements on pain intensity and duration of labor in primiparous women.
Public title
A comparative study of the effect of squats and butterfly movements on pain intensity and duration of labor stages.
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Primiparous women with gestational age 37 to 42 weeks A singleton who has full consent to participate in the study. Be a member of the Vertex embryo show The fetal position is occiput anterior. The mother is in the active phase and is 3 to 4 centimeters dilated.
Exclusion criteria:
Preterm birth Fetal distress Premature rupture of the water bag for more than 12 hours Severe gestational hypertension Preeclampsia and eclampsia severe anemia Abnormal presentation twins Receiving epidural or gastox anesthesia Suspected pelvic stenosis High maternal body mass index (more than 30) Deculman and Pervia History of previous caesarean section Posterior occiput position Suspected fetal macrosomia Maternal joint and skeletal problems Doubt to FGR Congenital fetal anomaly Known chronic disease in the mother (heart, kidney, diabetes, etc.). Attend childbirth preparation classes and yoga during pregnancy Mother's withdrawal from participation in the study at any stage of the research Any factor that causes an emergency cesarean section Use of vacuum Receiving any type of pain relief during the study If any abnormal changes occur in the fetal ECG or fetal distress occurs during the study
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 84
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling will be done by convenience sampling. In this way, primiparous women referring to the maternity ward of Iran Hospital, Iranshahr, who meet the inclusion criteria, were included in the study after receiving the necessary explanations and signing the informed consent form. After entering the study, participants will be assigned to one of three groups (squat exercise), (butterfly movement), (control group) using a block randomization method with an allocation ratio of 1:1:1. The random sequence of blocks is prepared before the study begins by a person who is not involved in conducting the research and collecting the data, using random number generation software. The allocation sequence is placed in opaque, sealed, opaque, numbered, and consecutive envelopes. After meeting the entry requirements and obtaining informed consent, the researcher opens the envelope corresponding to the same number and allocates the participant to one of the three study groups based on the group designated in the envelope. To prevent bias, the randomization sequence will be kept confidential until each participant is allocated, and it will not be possible to predict the assigned group. Given the nature of the intervention, blinding of participants and the researcher is not possible; however, statistical analysis of the data will be performed by someone who is unaware of the group allocation.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This study is the first clinical trial in the study area to directly compare the effects of two non-pharmacological interventions, including squats and butterfly pose (Baddha konasana), on pain intensity and duration of labor in primiparous women. Both phases of the intervention are performed during the active phase of labor and in the real delivery room environment. Also, the existence of three parallel groups, including the squat group, the butterfly group, and the control group, allows for a precise comparison of the effectiveness of these two interventions with usual care. The results of this study can provide practical evidence for the use of simple, low-cost, safe, and feasible interventions in the delivery room.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of iranshahr university of medical sciences
Street address
Moalem Boulevard
City
Iranshahr
Province
Sistan-va-Balouchestan
Postal code
9916643535
Approval date
2026-01-31, 1404/11/11
Ethics committee reference number
IR.IRSHUMS.REC.1404.039

Health conditions studied

1

Description of health condition studied
Child Birth
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Gestational age
Timepoint
Before intervention
Method of measurement
Based on the week of pregnancy recorded in the pregnancy record

2

Description
Economic situation
Timepoint
Before intervention
Method of measurement
Based on participant self-declaration and demographic information questionnaire

3

Description
The length of the first stage of labor
Timepoint
During the intervention
Method of measurement
From 3 cm to 10 cm dilation

4

Description
Length of the second stage of labor
Timepoint
During the intervention
Method of measurement
From 10 cm dilation to delivery of the fetus

5

Description
Desire to get pregnant
Timepoint
Before intervention
Method of measurement
Based on participant self-declaration and demographic information questionnaire

6

Description
Wife's job
Timepoint
Before intervention
Method of measurement
Based on participant self-declaration and demographic information questionnaire

7

Description
Spouse's level of education
Timepoint
Before intervention
Method of measurement
Based on participant self-declaration and demographic information questionnaire

8

Description
Mother's job
Timepoint
Before intervention
Method of measurement
Based on participant self-declaration and demographic information questionnaire

9

Description
Mother's level of education
Timepoint
Before intervention
Method of measurement
Based on participant self-declaration and demographic information questionnaire

10

Description
Severity of labor pain
Timepoint
After the intervention
Method of measurement
Measurement with a visual pain scale from zero to 10 at specific time intervals

11

Description
Mother's height
Timepoint
Before intervention
Method of measurement
According to the measurement carried out

12

Description
Mother's weight
Timepoint
Before intervention
Method of measurement
According to the measurement carried out

13

Description
Squat movements
Timepoint
During the intervention
Method of measurement
Performing squats according to the prescribed protocol

14

Description
Butterfly movements
Timepoint
During the intervention
Method of measurement
Performing the butterfly movement according to the established protocol

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: First intervention group: Squat movements are performed 5 times, each time for 3 to 5 deep breaths, held in the squat position for 30 seconds, and performed for 3 sets of 5, 30 seconds each, in 45 minutes. In the next 15 minutes, we will perform a vaginal examination and perform a triage, and a partograph form will be drawn. This process will continue until delivery.
Category
Diagnosis

2

Description
Intervention group: Second intervention group: The butterfly movement group also performs butterfly movements for 2 minutes under the supervision of a midwife, and for 3 sets of 2 minutes at 15-minute intervals, the butterfly movement is performed for 45 minutes, and for the next 15 minutes, we will perform a vaginal examination and perform a tracheotomy, and a partograph form will be drawn. This process will continue until delivery.
Category
Diagnosis

3

Description
Control group: The third group, which is the control group, receives routine hospital care.To eliminate the placebo effect, non-specific movement or soft touch will be used for the control group.
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Iran Hospital, Iranshahr
Full name of responsible person
Mahtab Karimi
Street address
Moalem Boulevard
City
Iranshahr
Province
Sistan-va-Balouchestan
Postal code
9916643535
Phone
+98 54 3721 2460
Fax
+98 54 3721 2460
Email
info@irshums.ac.ir
Web page address
http://iranhospital.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iranshahr University of Medical Sciences
Full name of responsible person
Masoud Kikha
Street address
Moalem Boulevar
City
Iranshahr
Province
Sistan-va-Balouchestan
Postal code
9916643535
Phone
+98 54 3721 3892
Fax
+98 54 3721 3892
Email
info@irshums.ac.ir
Web page address
http://irshums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iranshahr 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
Iranshahr University of Medical Sciences
Full name of responsible person
Mahtab karimi
Position
Master's degree student in midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Moalem Boulevard
City
Garmsar
Province
Semnan
Postal code
3596177683
Phone
+98 23 3422 2233
Email
mahtabkarimi7557@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iranshahr University of Medical Sciences
Full name of responsible person
Mahtab karimi
Position
Master's degree student in midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Fayyaz Bakhsh St., Kashani Blvd.,Takhti., Garmsar
City
Garmsar
Province
Semnan
Postal code
3596177683
Phone
+98 23 3422 2233
Email
mahtabkarimi7557@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iranshahr University of Medical Sciences
Full name of responsible person
Mahtab karimi
Position
Master's degree student in midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Fayyaz Bakhsh St., Kashani Blvd.,Takhti., Garmsar
City
Garmsar
Province
Semnan
Postal code
3596177683
Phone
+98 23 3422 2233
Email
mahtabkarimi7557@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Only part of the data, such as information related to the main outcome or the like, can be shared.
When the data will become available and for how long
Access period starts 6 months after results are published.
To whom data/document is available
It will only be available to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
To write an article and if you have an academic email
From where data/document is obtainable
To receive the required documents or data, applicants should send a message to the following email: mahtabkarimi7557@gmail.com Contact number: 09906449438
What processes are involved for a request to access data/document
Data will be sent within a week after reading the email.
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