Labor PainNCT05520060
The Effect of Continuous Midwifery Care at Birth on Labor Pain, Comfort and Satisfaction
A study testing Physical support, Psychospiritual support and Environmental and sociocultural support in people with Labor Pain, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
Introduction: Birth is a period in which biological, physical, emotional and social changes are experienced. Supportive care provided by the midwife ensures the adaptation of the woman to labor and improves her ability to cope with labor. Supportive care has positive effects on labor and maternal and infant health. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain
- What is being tested?
- Physical support, Psychospiritual support and Environmental and sociocultural support
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Dec 2022to 1 May 2024
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Volunteering to participate
- Knowing Turkish and being literate,
- Don't be in the latent phase.
Who cannot join
- high risk pregnancy
- Multiple pregnancy
- Breech presentation
- Induction of labor
- Emergency cesarean section indication
Trial locations and contacts
1 site in 1 country.
About this study
Introduction: Birth is a period in which biological, physical, emotional and social changes are experienced. Supportive care provided by the midwife ensures the adaptation of the woman to labor and improves her ability to cope with labor. Supportive care has positive effects on labor and maternal and infant health.
Purpose: This project aimed to determine the birth pain, comfort and satisfaction levels by considering the continuous midwifery care at birth with a holistic approach.
Method: The universe of this study, which will be conducted in randomized controlled experimental type, will consist of pregnant women who applied to Adana City Training and Research Hospital, Gynecology and Obstetrics Clinic, Delivery Room. The number of samples was calculated by G*power analysis, and it was aimed to carry out the research with 30 participants in the intervention group and 30 participants in the control group. Single-blind randomized assignment and block randomization will be performed to avoid selection bias. Data will be collected using face-to-face interview technique. The pre-test will be applied to pregnant women who apply to the delivery room in the latent phase. While the continuous midwifery care model will be applied to the intervention group, standard midwifery care will be applied to the control group. The final test will be done between 1-4 hours postpartum. The independent variable of the study is continuous midwifery care. The dependent variable is the introductory characteristics of women, labor pain, comfort and satisfaction levels. The data will be analyzed with appropriate analysis methods after performing normality tests.
Read the detailed description
During childbirth, women need someone's support. Providing continuous care to women with a supportive and holistic approach by midwives who care for women is seen as a potential that can improve labor pain management, birth comfort and satisfaction. The aim of this research is to determine the effect of continuous midwifery care at birth on labor pain, comfort and satisfaction levels.
For this purpose, the objectives are:
- To apply the continuous midwifery care model,
- To increase women's normal birth comfort and satisfaction,
- To create social awareness that midwives play a key role in normal birth,
- Reducing preventable maternal and infant and infant deaths due to care deficiencies,
- To reduce cesarean rates.
- Conditions
- Labor Pain
- Being tested
- Physical support, Psychospiritual support, Environmental and sociocultural support, Routine care
- Keywords
- Continuous midwifery care, supportive care, Labor pain, Comfort,
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical supportOther
Also called Supportive Care
Pharmacological and non-pharmacological methods in pain management, Mobilization, Position preferred by the woman, Fluid and nutritional support, Massage applications, Sacral pressure, Listening to music, Breathing and relaxation exercises
Psychospiritual supportOther
Also called Supportive Care
Effective communication, Encouragement to speak up and express fears, Support for faith-oriented practices
Environmental and sociocultural supportOther
Also called Supportive Care
egulating the temperature, light and sound of the room, Environment that promotes respect for privacy, Reducing environmental noise, Information, Social support, Talking about cultural practices, Social support
Routine careOther
Also called Health care
Admission to the delivery room, preparation for birth, delivery, postpartum care, etc.
| Study group | Role | What they receive |
|---|---|---|
| experimental | Experimental | The experimental group will be placed in continuous midwifery care. The continuous and supportive care stages to be presented at birth are planned within the framework of Kolcaba's comfort theory. According to this theory, interventions will be applied according to the physical, psychospiritual, environmental and sociocultural comfort needs of women. Receives: Other: Physical support; Other: Psychospiritual support; Other: Environmental and sociocultural support; Other: Routine care |
| Control | Placebo comparator | The experimental group will be placed in routine midwifery care. Receives: Other: Routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Birth Comfort Scale
Change from birth comfort between passive phase of childbirth and active phase of childbirth.
Measured: pre-intervention/passive phase of childbirth; immediately after the intervention/active phase of childbirth. An increase in the score is interpreted as an increase in comfort level.
Birth Satisfaction Scale
Birth satisfaction in the early postpartum period.
Measured: immediately after the intervention/1-4 hours postpartum. An increase in the score is interpreted as an increase in satisfaction level.
Scale of Pain Expression during Childbirth (ESVADOPA)
Change from pain expression level between passive phase of childbirth and active phase. of childbirth.
Measured: pre-intervention/passive phase of childbirth; immediately after the intervention/active phase of childbirth.An increase in the score is interpreted as an increase in the expression of pain.
Visual Analog Scale
Change from pain between passive phase of childbirth and active phase of childbirth.
Measured: pre-intervention/passive phase of childbirth; immediately after the intervention/active phase of childbirth. An increase in the score is interpreted as an increase in pain.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start5 Dec 2022
- Primary completion15 Jan 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor PainStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayseren Cevik, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05520060
- Sponsor's protocol ID
- 03.06.2022/49
- Status last verified
- Jan 2025
- First submitted
- 23 Aug 2022
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Continuous Midwifery Care at Birth on Labor Pain, Comfort and Satisfaction
- ClinicalTrials.gov ID
- NCT05520060
- Acronym / sponsor ID
- 03.06.2022/49
- Conditions
- Labor Pain
- Keywords
- Continuous midwifery care, supportive care, Labor pain, Comfort,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 5 Dec 2022 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 29 Aug 2022 (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.
Introduction: Birth is a period in which biological, physical, emotional and social changes are experienced. Supportive care provided by the midwife ensures the adaptation of the woman to labor and improves her ability to cope with labor. Supportive care has positive effects on labor and maternal and infant health.
Purpose: This project aimed to determine the birth pain, comfort and satisfaction levels by considering the continuous midwifery care at birth with a holistic approach.
Method: The universe of this study, which will be conducted in randomized controlled experimental type, will consist of pregnant women who applied to Adana City Training and Research Hospital, Gynecology and Obstetrics Clinic, Delivery Room. The number of samples was calculated by G*power analysis, and it was aimed to carry out the research with 30 participants in the intervention group and 30 participants in the control group. Single-blind randomized assignment and block randomization will be performed to avoid selection bias. Data will be collected using face-to-face interview technique. The pre-test will be applied to pregnant women who apply to the delivery room in the latent phase. While the continuous midwifery care model will be applied to the intervention group, standard midwifery care will be applied to the control group. The final test will be done between 1-4 hours postpartum. The independent variable of the study is continuous midwifery care. The dependent variable is the introductory characteristics of women, labor pain, comfort and satisfaction levels. The data will be analyzed with appropriate analysis methods after performing normality tests.
Detailed description
During childbirth, women need someone's support. Providing continuous care to women with a supportive and holistic approach by midwives who care for women is seen as a potential that can improve labor pain management, birth comfort and satisfaction. The aim of this research is to determine the effect of continuous midwifery care at birth on labor pain, comfort and satisfaction levels.
For this purpose, the objectives are:
- To apply the continuous midwifery care model,
- To increase women's normal birth comfort and satisfaction,
- To create social awareness that midwives play a key role in normal birth,
- Reducing preventable maternal and infant and infant deaths due to care deficiencies,
- To reduce cesarean rates.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental | Experimental | Other: Physical support, Other: Psychospiritual support, Other: Environmental and sociocultural support, Other: Routine careThe experimental group will be placed in continuous midwifery care. The continuous and supportive care stages to be presented at birth are planned within the framework of Kolcaba's comfort theory. According to this theory, interventions will be applied according to the physical, psychospiritual, environmental and sociocultural comfort needs of women. |
| Control | Placebo comparator | Other: Routine careThe experimental group will be placed in routine midwifery care. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Volunteering to participate
- Knowing Turkish and being literate,
- Don't be in the latent phase.
Key exclusion criteria (5 listed)
- high risk pregnancy
- Multiple pregnancy
- Breech presentation
- Induction of labor
- Emergency cesarean section indication
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 |
|---|---|---|
| Physical supportAlso: Supportive CarePharmacological and non-pharmacological methods in pain management, Mobilization, Position preferred by the woman, Fluid and nutritional support, Massage applications, Sacral pressure, Listening to music, Breathing and relaxation exercises | Other | experimental |
| Psychospiritual supportAlso: Supportive CareEffective communication, Encouragement to speak up and express fears, Support for faith-oriented practices | Other | experimental |
| Environmental and sociocultural supportAlso: Supportive Careegulating the temperature, light and sound of the room, Environment that promotes respect for privacy, Reducing environmental noise, Information, Social support, Talking about cultural practices, Social support | Other | experimental |
| Routine careAlso: Health careAdmission to the delivery room, preparation for birth, delivery, postpartum care, etc. | Other | Control, experimental |
Primary outcome
Birth Comfort Scale
Time frame: pre-intervention/passive phase of childbirth; immediately after the intervention/active phase of childbirth. An increase in the score is interpreted as an increase in comfort level.
Change from birth comfort between passive phase of childbirth and active phase of childbirth.
Birth Satisfaction Scale
Time frame: immediately after the intervention/1-4 hours postpartum. An increase in the score is interpreted as an increase in satisfaction level.
Birth satisfaction in the early postpartum period.
Scale of Pain Expression during Childbirth (ESVADOPA)
Time frame: pre-intervention/passive phase of childbirth; immediately after the intervention/active phase of childbirth.An increase in the score is interpreted as an increase in the expression of pain.
Change from pain expression level between passive phase of childbirth and active phase. of childbirth.
Visual Analog Scale
Time frame: pre-intervention/passive phase of childbirth; immediately after the intervention/active phase of childbirth. An increase in the score is interpreted as an increase in pain.
Change from pain between passive phase of childbirth and active phase of childbirth.
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 28 Jan 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical support, Psychospiritual support and Environmental and sociocultural support in people with Labor Pain, run by Cukurova University 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 3 inclusion and 5 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 28 Jan 2025. 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. Some participants in this study may receive a placebo. 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?
Birth Comfort Scale (time frame: pre-intervention/passive phase of childbirth; immediately after the intervention/active phase of childbirth. An increase in the score is interpreted as an increase in comfort level.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jan 2025.