UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059597 |
|---|---|
| Receipt number | R000068169 |
| Scientific Title | The Effect of Mirror Use During the Second Stage of Labor on Labor Duration, Women's Pain Levels, Perceptions of Respectful Maternity Care, Birth Experience, and Postpartum Comfort: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2025/11/20 |
| Last modified on | 2025/11/03 02:28:55 |
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Basic information
Public title
The Effect of Mirror Use During the Second Stage of Labor on Labor Duration, Women's Pain Levels, Perceptions of Respectful Maternity Care, Birth Experience, and Postpartum Comfort: A Randomized Controlled Trial
Acronym
The Effect of Mirror Use During The Second Stage of Labor on The Women's Labor Process And Experience
Scientific Title
The Effect of Mirror Use During the Second Stage of Labor on Labor Duration, Women's Pain Levels, Perceptions of Respectful Maternity Care, Birth Experience, and Postpartum Comfort: A Randomized Controlled Trial
Scientific Title:Acronym
The Effect of Mirror Use During The Second Stage of Labor on The Women's Labor Process And Experience
Region
| Asia(except Japan) |
Condition
Condition
Supportive practices for childbirth and women during the intrapartum period
Classification by specialty
| Obstetrics and Gynecology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study was designed to determine the effect of mirror use during the second stage of labor on the duration of labor, the woman's pain levels, perception of respectful maternity care, birth experience, and postpartum comfort.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Pain level and duration of labor
Description: Pain was measured twice using the Visual Analog Scale (1-10; 10 = highest pain) at the time of admission and immediately after the placenta was delivered. The duration of the second stage of labor was recorded from complete cervical dilation to delivery. All assessments were performed face-to-face by the researchers.
Time Frame: During the second stage of labor, from full cervical dilation until delivery of the baby (120 minutes)
Key secondary outcomes
Womens perception of respectful maternity care, birth experience, and postpartum comfort
Description: Respectful Maternal Care Perception Scale (19-95), Postpartum Comfort Scale (34-170), and Birth Experience Scale were measured face-to-face. Higher scores indicate higher perceptions of respectful care, comfort, and positive birth experience.
Time Frame: Within 2 hours after delivery
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Interventional Group :Mirror Group
During the second stage of labor, a mirror will be held so that the woman can observe the birth of her baby until delivery. The mirror was placed opposite the delivery table so that the woman could see her perineum.Standard care was also continued.
Interventions/Control_2
Control Group: Standard Care
During the second stage of labor, women received only standard care.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 39 | years-old | > |
Gender
Female
Key inclusion criteria
Inclusion Criteria:
Volunteers willing to participate in the study,
Literate,
Knowing Turkish,
Admitted to the delivery room,
Primipar,
Without a high-risk pregnancy,
With a singleton pregnancy,
Aged 18-39,
Pregnant women with a gestational age of 37-41 weeks,
Women without psychological issues that would prevent them from participating in the study will be included in the study.
Key exclusion criteria
Exclusion Criteria:
Women with chronic illnesses,
Women with vision problems,
Women experiencing high-risk pregnancies,
Women unable to understand the questionnaires,
Women with psychiatric illnesses (diagnosed and undergoing treatment) will not be included in the study.
Target sample size
102
Research contact person
Name of lead principal investigator
| 1st name | Bilgesu |
| Middle name | |
| Last name | CELIK |
Organization
Cankiri Karatekin University, Faculty of Health Sciences, Department of Midwifery
Division name
Midwifery
Zip code
18100
Address
Cankiri Karatekin University Uluyazi Campus
TEL
05078506039
sugebil97@gmail.com
Public contact
Name of contact person
| 1st name | Bilgesu |
| Middle name | |
| Last name | CELIK |
Organization
Cankiri Karatekin University, Faculty of Health Sciences, Department of Midwifery
Division name
Midwifery
Zip code
18100
Address
Cankiri Karatekin University Uluyazi Campus
TEL
+90-507-850-6039
Homepage URL
sugebil97@gmail.com
Sponsor or person
Institute
Cankiri Karatekin University, Faculty of Health Sciences, Department of Midwifery
Institute
Department
Personal name
Funding Source
Organization
Self-funded
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Selcuk University Faculty of Health Sciences Ethics Committee for Non-Interventional Clinical Investigations
Address
Selcuk University Faculty of Health Sciences Aladdin Keykubat Campus 299/1 42250 Selcuklu/KONYA
Tel
03322416211
etikkurulusbf@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Private Konya Metropolitan Hospital (Konya)
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | Month | 20 | Day |
Related information
URL releasing protocol
Not applicable
Publication of results
Unpublished
Result
URL related to results and publications
Not applicable
Number of participants that the trial has enrolled
102
Results
The study was not registered as a clinical trial. After planning the study, participants were randomly assigned to groups. The intervention group received mirror therapy during the second stage of labor, while the control group received only standard care. A total of 102 participants completed the study, with 51 in the intervention (mirror) group and 51 in the control group.
Results date posted
| 2025 | Year | 10 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2025 | Year | 12 | Month | 31 | Day |
Baseline Characteristics
Study Type:Randomized Controlled Trial
Number and Characteristics of Participants: 102 primiparous women meeting the inclusion criteria
Intervention Type:he intervention group received mirror therapy during the second stage of labor, while the control group received standard care only.
Duration:The mirror intervention was applied throughout the second stage of labor (approximately 30-120 minutes).
Measurements:Pain levels were assessed using the Visual Analog Scale (VAS) immediately upon admission to the delivery room and immediately after the placenta was delivered.The duration of the second stage of labor was recorded in minutes. Within the first two hours after delivery, the Womens Perceived Respectful Maternity Care Scale, the Birth Experience Scale, and the Postpartum Comfort Scale were administered and evaluated.
Participant flow
Applicant Participants: 200
Excluded: Does not meet inclusion criteria:96
Participants Included:114
Randomization
Intervention Group:57
Intervention Team: 4 people Emergency cesarean
Intervention Group: 53 people
Mirror intervention during the second stage of labor
Intervention Group: 2 people
Decided not to intervene.
Intervention Group: 51 people
Control Group:57
Control Group: 5 people declined to participate in the study.
Control Group: 52 Received standard care.
Control Group: 1 person Underwent emergency cesarean section
Control Group: 51 people
Adverse events
none
Outcome measures
Visual Analog Scale:Pain was measured using the Visual Analog Scale (VAS) immediately upon admission to the delivery room and immediately after the placenta was delivered.
Intrapartum Period:The second stage of labor was measured in minutes, from full cervical dilation to delivery.
Respectful Maternal Care Scale, Birth Experience Scale:It was applied within the first two hours after birth.
Postpartum Comfort Scale:It was applied within the first two hours after birth.
Birth Experience:It was applied within the first two hours after birth.
A sample size of 102 participants was selected, which is 10% larger than the target sample size of 90 participants. This was done to ensure the reliability of the results.
Plan to share IPD
IPD will not be shared.
IPD sharing Plan description
No individual participant data will be shared due to confidentiality and privacy concerns.
Progress
Recruitment status
Completed
Date of protocol fixation
| 2025 | Year | 03 | Month | 05 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 05 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2025 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2025 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2025 | Year | 10 | Month | 31 | Day |
Other
Other related information
The study was conducted at a private hospital in Konya province. Data Analysis. The Chi-square test was applied to compare categorical data. For scale score comparisons, the Mann Whitney U test and Kruskal Wallis test were used since the data were non-parametrically distributed.
The study had no sponsor or funder.
Management information
Registered date
| 2025 | Year | 10 | Month | 30 | Day |
Last modified on
| 2025 | Year | 11 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068169
| Research Plan | |
|---|---|
| Registered date | File name |
| 2025/11/03 | STUDY ABOUT.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2025/11/03 | STUDY ABOUT.xlsx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2025/11/03 | STUDY ABOUT.xlsx |
Single case data URL
Value
https://center6.umin.ac.jp/ice/68169
