Perineal InjuryNCT06005077
Perineal Massage and Warm Application in Labor
A study testing Perineal Massage Group, Perineal Warm Compress Application Group and Perineal Massage and Perineal Warm Compress Application Group in people with Perineal Injury and Pain, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to determine the effect of perineal massage and warm compress application at first and second stage of labor on perineal trauma, pain and delivery comfort. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Perineal Injury, Pain, Labor
- What is being tested?
- Perineal Massage Group, Perineal Warm Compress Application Group and Perineal Massage and Perineal Warm Compress Application Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2018to 1 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Primiparous
- 38"week of pregnancy
- Singleton pregnancy
- Cervical dilatation 3"cm
- Cephalic presentation
Who cannot join
- Chronic disease
- Presence of fetal macrosomia
- Presence of uterin surgery
- Presence of fetal anomaly
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effect of Perineal Massage and Warm Application on Perineal Trauma, Pain and Birth Comfort in Labor
The aim of this study is to determine the effect of perineal massage and warm compress application at first and second stage of labor on perineal trauma, pain and delivery comfort.
Read the detailed description
Perineal trauma is the damage caused by rupture, laceration or episiotomy during birth. Birth-related perineal trauma can lead to many short and long-term physical and psychological morbidities that affect the woman's life. Problems such as pain, bleeding and delay in the attachment of mother and newborn appear in the early postpartum period. In the following period problems such as prolapse, incontinence, sexual dysfunction and anxiety may be experienced.
This randomised controlled study was executed at a research hospital between May 2018 - September 2019. The sample of study is made consisted of three intervention groups and a control group of total 120 pregnant women by randomisation method. Perineal massage, perineal warm compress application, perineal massage and warm compress was done to the intervention groups respectively. Nothing was done to the control group. Perineal massage was given for 10 minutes, warm compress application was done 30 minutes three times when cervical dilatation 3-4 cm, 5-7 cm and 8-10 cm respectively. The data was collected by using Socio-Demographic and Obstetric Data Collection Form, First and Second Stage of Labor Stage Data Collection Form, Childbirth Comfort Scale, Newborn Data Collection Form, Perineal Trauma and Bleeding Monitorisation/ Measurement Form, Visual Analogue Scale, Birth Satisfaction Scale and Perineal Massage and Perineal Warm Compress Application Satisfaction Evaluation Form. When evaluating the data; number, percentage, mean, standard deviation, median, ANOVA Test, Tukey Test, Kruskal Wallis Test, Paired Sample T Test, Friedman Test, Ki-Square Test and Fisher's Exact was used.
- Conditions
- Perineal Injury, Pain, Labor
- Being tested
- Perineal Massage Group, Perineal Warm Compress Application Group, Perineal Massage and Perineal Warm Compress Application Group
- Keywords
- Labor, Perineal massage, Perineal warm compress, Perineal Trauma
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perineal Massage GroupOther
While the pregnant woman was in the lithotomy position, massage was applied with two fingers and rhythmic U-shaped movements starting from the side walls 3-4 cm inside the vagina and towards the rectum. This implementation was done for 10 minutes in three stages according to cervical dilatation. It was applied when the cervical dilatation was 3-4 cm, 5-7 cm, and 8-10 cm.
Perineal Warm Compress Application GroupOther
Sterile compresses kept in hot water of 40 C were placed on the perineum. Compresses that cooled down and became dirty were changed every 5-8 minutes. This implementation was done for 30 minutes in three stages according to cervical dilatation. It was applied when the cervical dilatation was 3-4 cm, 5-7 cm, and 8-10 cm.
Perineal Massage and Perineal Warm Compress Application GroupOther
When the cervical dilatation was 3-4 cm, 30 minutes of warm compress and 10 minutes of perineal massage were performed. These two methods were applied when the cervical dilatation was 5-7 cm and 8-10 cm as well .
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | After the hospitalization procedures were completed, the pregnant women in the control group were informed and their written consents were obtained. No intervention was performed on these pregnant women other than routine hospital practices. Data collection forms were applied. |
| Perineal Massage | Experimental | While the pregnant woman was in the lithotomy position, massage was applied with two fingers and rhythmic U-shaped movements starting from the side walls 3-4 cm inside the vagina and towards the rectum. This implementation was done for 10 minutes in three stages according to cervical dilatation. It was applied when the cervical dilatation was 3-4 cm, 5-7 cm, and 8-10 cm. Receives: Other: Perineal Massage Group |
| Perineal Warm Compress Application | Experimental | Sterile compresses kept in hot water of 40 C were placed on the perineum. Compresses that cooled down and became dirty were changed every 5-8 minutes. This implementation was done for 30 minutes in three stages according to cervical dilatation. It was applied when the cervical dilatation was 3-4 cm, 5-7 cm, and 8-10 cm. Receives: Other: Perineal Warm Compress Application Group |
| Perineal Massage and Perineal Warm Compress Application | Experimental | When the cervical dilatation was 3-4 cm, 30 minutes of warm compress and 10 minutes of perineal massage were performed. These two methods were applied when the cervical dilatation was 5-7 cm and 8-10 cm as well. Receives: Other: Perineal Massage Group; Other: Perineal Massage and Perineal Warm Compress Application Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Socio-Demographic and Obstetric Data Collection Form
The Socio-Demographic and Obstetric Data Form was used to determine the socio-demographic and obstetric characteristics of the participants. This form, created by the investigators, includes 15 questions on age, height, weight, education level, and gestational week of the pregnant women, the way pregnancy occured, and the health problems experienced during pregnancy.
Measured: Baseline
First and Second Stage of Labor Stage Data Collection Form
The First and Second Stage of Labor Data Form and the Newborn Data Form were used to note down the applications performed on the pregnant woman during the first and second stages of labor and on the newborn after delivery. The form created by the investigators following the review of the literature consists of three parts. In the first part, there are questions regarding the applications such as dilatation, wiping, drugs used in the first stage, amniotomy, and bladder catheterization performed when the pregnant woman is admitted into the delivery room. In the second part, there are questions on the application of local anesthesia in the second stage of labor, protection of the perineum, and the type of pushing. The third part consists of questions regarding the height, weight and APGAR measurement of the newborn. This form includes 33 questions in total.
Measured: During procedure
Childbirth Comfort Scale
The Childbirth Comfort Scale (CCS) is used to determine the comfort level at birth. This scale is a 5-point Likert type scale and consists of 14 items. Each item is rated between 1-5 (1: Strongly disagree, 2: Mostly disagree, 3: Partially agree, 4: Mostly agree, 5: Completely agree). The scale has a four-factor structure: physical, psychospiritual, social and environmental.
Measured: During the procedure
Birth Satisfaction Scale
The Birth Satisfaction Scale (BSS) is used to evaluate birth satisfaction. This scale is a 5-point Likert-type scale and consists of 30 items. The three main themes of the scale are quality of care, personal characteristics of the women, and stress experienced during childbirth. A minimum of 30 and a maximum of 150 points can be obtained from the scale. Higher scores indicate higher levels of satisfaction.
Measured: In the first 1 hour after birth
Perineal Trauma and Bleeding Monitorisation/Measurement Form
The Perineal Trauma, Postpartum Bleeding and Episiotomy Length Evaluation Form was used to record data on perineal trauma and amount of bleeding. The form, created by theinvestigators, consists of 13 questions evaluating conditions such as episiotomy, type of perineal trauma, location and degree of trauma, and postpartum bleeding.
Measured: In the first 1 hour after birth
Visual Analogue Scale
The Visual Analog Scale (VAS) is a one-dimensional measurement tool used to show perceived pain and its severity. One end of the scale indicates "painlessness (0)" and the other end indicates "the most severe pain possible (10)" .
Measured: During procedure
Birth Satisfaction Scale
The Newborn Characteristics Data Collection Form consists of 7 questions including the newborn's height, weight and APGAR assessment.
Measured: In the first 1 hour after birth
Perineal Massage and Perineal Warm Compress Application Satisfaction Evaluation Form
This form was used to record the phases, periods and durations of perineal massage and perineal heat application, as well as to evaluate the satisfaction with the application. A visual scale graded from 0 to 10 was used in the satisfaction evaluation. It was rated as "0" not at all satisfied, "10" very satisfied.In addition, the participants were asked whether the application was beneficial, whether participants would prefer it when they gave birth again, and whether they would recommend it to others. It was created by the researcher and expert approval was obtained.
Measured: In the first 1 hour after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start1 May 2018
- Primary completion1 Jun 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Perineal InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamze Acavut, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
- Investigators
- Gamze Acavut, Principal investigator, Ankara Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06005077
- Sponsor's protocol ID
- 2018/13
- Status last verified
- Aug 2023
- First submitted
- 30 Jan 2023
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ducarme G, Pizzoferrato AC, de Tayrac R, Schantz C, Thubert T, Le Ray C, Riethmuller D, Verspyck E, Gachon B, Pierre F, Artzner F, Jacquetin B, Fritel X. Perineal prevention and protection in obstetrics: CNGOF clinical practice guidelines. J Gynecol Obstet Hum Reprod. 2019 Sep;48(7):455-460. doi: 10.1016/j.jogoh.2018.12.002. Epub 2018 Dec 12.
PubMed 30553051Fukami T, Koga H, Goto M, Ando M, Matsuoka S, Tohyama A, Yamamoto H, Nakamura S, Koyanagi T, To Y, Kondo H, Eguchi F, Tsujioka H. Incidence and risk factors for postpartum hemorrhage among transvaginal deliveries at a tertiary perinatal medical facility in Japan. PLoS One. 2019 Jan 9;14(1):e0208873. doi: 10.1371/journal.pone.0208873. eCollection 2019.
PubMed 30625154Barasinski C, Debost-Legrand A, Lemery D, Vendittelli F. Practices during the active second stage of labor: A survey of French midwives. Midwifery. 2018 May;60:48-55. doi: 10.1016/j.midw.2018.02.001. Epub 2018 Feb 8.
PubMed 29494852Difranco JT, Romano AM, Keen R. Care practice #5: spontaneous pushing in upright or gravity-neutral positions. J Perinat Educ. 2007 Summer;16(3):35-8. doi: 10.1624/105812407X217138.
PubMed 18566649Acavut G, Guvenc G, Karasahin KE. The Effectiveness of Massage and Warm Compresses on Perineal Trauma, Hemorrhage, Length of Episiotomy and Pain: A Randomized Controlled Trial. Z Geburtshilfe Neonatol. 2026 Apr;230(2):155-161. doi: 10.1055/a-2730-1313. Epub 2025 Nov 19.
PubMed 41260484
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Perineal Massage and Warm Application on Perineal Trauma, Pain and Birth Comfort in Labor
- ClinicalTrials.gov ID
- NCT06005077
- Acronym / sponsor ID
- 2018/13
- Conditions
- Perineal Injury, Pain, Labor
- Keywords
- Labor, Perineal massage, Perineal warm compress, Perineal Trauma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip FakultesiUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 22 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to determine the effect of perineal massage and warm compress application at first and second stage of labor on perineal trauma, pain and delivery comfort.
Detailed description
Perineal trauma is the damage caused by rupture, laceration or episiotomy during birth. Birth-related perineal trauma can lead to many short and long-term physical and psychological morbidities that affect the woman's life. Problems such as pain, bleeding and delay in the attachment of mother and newborn appear in the early postpartum period. In the following period problems such as prolapse, incontinence, sexual dysfunction and anxiety may be experienced.
This randomised controlled study was executed at a research hospital between May 2018 - September 2019. The sample of study is made consisted of three intervention groups and a control group of total 120 pregnant women by randomisation method. Perineal massage, perineal warm compress application, perineal massage and warm compress was done to the intervention groups respectively. Nothing was done to the control group. Perineal massage was given for 10 minutes, warm compress application was done 30 minutes three times when cervical dilatation 3-4 cm, 5-7 cm and 8-10 cm respectively. The data was collected by using Socio-Demographic and Obstetric Data Collection Form, First and Second Stage of Labor Stage Data Collection Form, Childbirth Comfort Scale, Newborn Data Collection Form, Perineal Trauma and Bleeding Monitorisation/ Measurement Form, Visual Analogue Scale, Birth Satisfaction Scale and Perineal Massage and Perineal Warm Compress Application Satisfaction Evaluation Form. When evaluating the data; number, percentage, mean, standard deviation, median, ANOVA Test, Tukey Test, Kruskal Wallis Test, Paired Sample T Test, Friedman Test, Ki-Square Test and Fisher's Exact was used.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –After the hospitalization procedures were completed, the pregnant women in the control group were informed and their written consents were obtained. No intervention was performed on these pregnant women other than routine hospital practices. Data collection forms were applied. |
| Perineal Massage | Experimental | Other: Perineal Massage GroupWhile the pregnant woman was in the lithotomy position, massage was applied with two fingers and rhythmic U-shaped movements starting from the side walls 3-4 cm inside the vagina and towards the rectum. This implementation was done for 10 minutes in three stages according to cervical dilatation. It was applied when the cervical dilatation was 3-4 cm, 5-7 cm, and 8-10 cm. |
| Perineal Warm Compress Application | Experimental | Other: Perineal Warm Compress Application GroupSterile compresses kept in hot water of 40 C were placed on the perineum. Compresses that cooled down and became dirty were changed every 5-8 minutes. This implementation was done for 30 minutes in three stages according to cervical dilatation. It was applied when the cervical dilatation was 3-4 cm, 5-7 cm, and 8-10 cm. |
| Perineal Massage and Perineal Warm Compress Application | Experimental | Other: Perineal Massage Group, Other: Perineal Massage and Perineal Warm Compress Application GroupWhen the cervical dilatation was 3-4 cm, 30 minutes of warm compress and 10 minutes of perineal massage were performed. These two methods were applied when the cervical dilatation was 5-7 cm and 8-10 cm as well. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Primiparous
- 38"week of pregnancy
- Singleton pregnancy
- Cervical dilatation 3"cm
- Cephalic presentation
Key exclusion criteria (4 listed)
- Chronic disease
- Presence of fetal macrosomia
- Presence of uterin surgery
- Presence of fetal anomaly
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perineal Massage GroupWhile the pregnant woman was in the lithotomy position, massage was applied with two fingers and rhythmic U-shaped movements starting from the side walls 3-4 cm inside the vagina and towards the rectum. This implementation was done for 10 minutes in three stages according to cervical dilatation. It was applied when the cervical dilatation was 3-4 cm, 5-7 cm, and 8-10 cm. | Other | Perineal Massage, Perineal Massage and Perineal Warm Compress Application |
| Perineal Warm Compress Application GroupSterile compresses kept in hot water of 40 C were placed on the perineum. Compresses that cooled down and became dirty were changed every 5-8 minutes. This implementation was done for 30 minutes in three stages according to cervical dilatation. It was applied when the cervical dilatation was 3-4 cm, 5-7 cm, and 8-10 cm. | Other | Perineal Warm Compress Application |
| Perineal Massage and Perineal Warm Compress Application GroupWhen the cervical dilatation was 3-4 cm, 30 minutes of warm compress and 10 minutes of perineal massage were performed. These two methods were applied when the cervical dilatation was 5-7 cm and 8-10 cm as well . | Other | Perineal Massage and Perineal Warm Compress Application |
Primary outcome
Socio-Demographic and Obstetric Data Collection Form
Time frame: Baseline
The Socio-Demographic and Obstetric Data Form was used to determine the socio-demographic and obstetric characteristics of the participants. This form, created by the investigators, includes 15 questions on age, height, weight, education level, and gestational week of the pregnant women, the way pregnancy occured, and the health problems experienced during pregnancy.
First and Second Stage of Labor Stage Data Collection Form
Time frame: During procedure
The First and Second Stage of Labor Data Form and the Newborn Data Form were used to note down the applications performed on the pregnant woman during the first and second stages of labor and on the newborn after delivery. The form created by the investigators following the review of the literature consists of three parts. In the first part, there are questions regarding the applications such as dilatation, wiping, drugs used in the first stage, amniotomy, and bladder catheterization performed when the pregnant woman is admitted into the delivery room. In the second part, there are questions on the application of local anesthesia in the second stage of labor, protection of the perineum, and the type of pushing. The third part consists of questions regarding the height, weight and APGAR measurement of the newborn. This form includes 33 questions in total.
Childbirth Comfort Scale
Time frame: During the procedure
The Childbirth Comfort Scale (CCS) is used to determine the comfort level at birth. This scale is a 5-point Likert type scale and consists of 14 items. Each item is rated between 1-5 (1: Strongly disagree, 2: Mostly disagree, 3: Partially agree, 4: Mostly agree, 5: Completely agree). The scale has a four-factor structure: physical, psychospiritual, social and environmental.
Birth Satisfaction Scale
Time frame: In the first 1 hour after birth
The Birth Satisfaction Scale (BSS) is used to evaluate birth satisfaction. This scale is a 5-point Likert-type scale and consists of 30 items. The three main themes of the scale are quality of care, personal characteristics of the women, and stress experienced during childbirth. A minimum of 30 and a maximum of 150 points can be obtained from the scale. Higher scores indicate higher levels of satisfaction.
Perineal Trauma and Bleeding Monitorisation/Measurement Form
Time frame: In the first 1 hour after birth
The Perineal Trauma, Postpartum Bleeding and Episiotomy Length Evaluation Form was used to record data on perineal trauma and amount of bleeding. The form, created by theinvestigators, consists of 13 questions evaluating conditions such as episiotomy, type of perineal trauma, location and degree of trauma, and postpartum bleeding.
Visual Analogue Scale
Time frame: During procedure
The Visual Analog Scale (VAS) is a one-dimensional measurement tool used to show perceived pain and its severity. One end of the scale indicates "painlessness (0)" and the other end indicates "the most severe pain possible (10)" .
Birth Satisfaction Scale
Time frame: In the first 1 hour after birth
The Newborn Characteristics Data Collection Form consists of 7 questions including the newborn's height, weight and APGAR assessment.
Perineal Massage and Perineal Warm Compress Application Satisfaction Evaluation Form
Time frame: In the first 1 hour after birth
This form was used to record the phases, periods and durations of perineal massage and perineal heat application, as well as to evaluate the satisfaction with the application. A visual scale graded from 0 to 10 was used in the satisfaction evaluation. It was rated as "0" not at all satisfied, "10" very satisfied.In addition, the participants were asked whether the application was beneficial, whether participants would prefer it when they gave birth again, and whether they would recommend it to others. It was created by the researcher and expert approval was obtained.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
- Background: PubMed 30553051Ducarme G, Pizzoferrato AC, de Tayrac R, Schantz C, Thubert T, Le Ray C, Riethmuller D, Verspyck E, Gachon B, Pierre F, Artzner F, Jacquetin B, Fritel X. Perineal prevention and protection in obstetrics: CNGOF clinical practice guidelines. J Gynecol Obstet Hum Reprod. 2019 Sep;48(7):455-460. doi: 10.1016/j.jogoh.2018.12.002. Epub 2018 Dec 12.
- Background: PubMed 30625154Fukami T, Koga H, Goto M, Ando M, Matsuoka S, Tohyama A, Yamamoto H, Nakamura S, Koyanagi T, To Y, Kondo H, Eguchi F, Tsujioka H. Incidence and risk factors for postpartum hemorrhage among transvaginal deliveries at a tertiary perinatal medical facility in Japan. PLoS One. 2019 Jan 9;14(1):e0208873. doi: 10.1371/journal.pone.0208873. eCollection 2019.
- Background: PubMed 29494852Barasinski C, Debost-Legrand A, Lemery D, Vendittelli F. Practices during the active second stage of labor: A survey of French midwives. Midwifery. 2018 May;60:48-55. doi: 10.1016/j.midw.2018.02.001. Epub 2018 Feb 8.
- Background: PubMed 18566649Difranco JT, Romano AM, Keen R. Care practice #5: spontaneous pushing in upright or gravity-neutral positions. J Perinat Educ. 2007 Summer;16(3):35-8. doi: 10.1624/105812407X217138.
- Derived from this study: PubMed 41260484Acavut G, Guvenc G, Karasahin KE. The Effectiveness of Massage and Warm Compresses on Perineal Trauma, Hemorrhage, Length of Episiotomy and Pain: A Randomized Controlled Trial. Z Geburtshilfe Neonatol. 2026 Apr;230(2):155-161. doi: 10.1055/a-2730-1313. Epub 2025 Nov 19.
- Individual participant dataSharing planned: No
Related trials for Perineal Injury
Recruiting
Improving Postpartum Quality of Life Through Enhanced Perineal Care Training
Postpartum Quality of Life, Peripartal Maternal Trauma
Enrolling by invitation
Effect of a Standardized Moisture-Care Protocol Using Skin Barrier Spray on Prevention of Pressure Injuries in the Perineal-Sacral Area Among Incontinent Inpatients: A 3-month Pilot Study.
Pressure Injury, Pressure Injury Prevention
Not yet recruiting
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
Pelvic Floor Dysfunction, Perineal Laceration
Not yet recruiting
Ward-Level Implementation and Post-Market Clinical Follow-up Study of ASISU Under Routine Clinical Practice
Perineal Trauma
Not yet recruiting
THE EFFECT OF 360° VIDEO-ASSISTED TRAINING ON VERTICAL BIRTH POSITIONS IN PRIMIPAROUS WOMEN ON FEAR OF CHILDBIRTH, SELF-EFFICACY IN CHILDBIRTH, SATISFACTION WITH CHILDBIRTH, AND PERINEAL TRAUMA: A RANDOMIZED CONTROLLED TRIAL
Childbirth
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gamze Acavut principal investigator
Ankara Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perineal Massage Group, Perineal Warm Compress Application Group and Perineal Massage and Perineal Warm Compress Application Group in people with Perineal Injury and Pain, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Socio-Demographic and Obstetric Data Collection Form (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06005077, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2023.