Effect of Continuous Midwifery Support on Comfort, Sleep, and Breastfeeding Self-Efficacy in Primiparous Women: A Follow-Up From Pregnancy to MotherhoodNCT07165288
Effect of Continuous Midwifery Support on Comfort, Sleep Quality, and Breastfeeding Self-Efficacy in Primiparous Women: A Follow-Up Study From Pregnancy to Motherhood
A study testing Continuous midwife support care, Pilates ball usage and warm shower in people with Effect of Continuous Midwifery Support on Comfort, Sleep, and Breastfeeding Self-Efficacy in Primiparous Women: A Follow-Up From Pregnancy to Motherhood, run by Palu Devlet Hastanesi at 1 site in Turkey (Türkiye).
Trial summary
The study was conducted to determine the effect of continuous midwife support provided to primiparous pregnant women until the postpartum period on comfort, sleep quality and breastfeeding self-sufficiency. Read more about this study
- Who is it for?
- Ages 18 to 36 years, women only
- Conditions the study is for
- Effect of Continuous Midwifery Support on Comfort, Sleep, and Breastfeeding Self-Efficacy in Primiparous Women: A Follow-Up From Pregnancy to Motherhood
- What is being tested?
- Continuous midwife support care, Pilates ball usage and warm shower
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 20 Dec 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 18 to 36 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- All pregnant women who communicate verbally and do not have a reading or writing disability,
- Having a singleton healthy pregnancy,
- Having a primiparous pregnancy in the 36th week of pregnancy,
- Not a midwife by profession,
- Not having any diagnosed psychiatric problems were included.
Who cannot join
- Women who developed an indication for cesarean section were excluded.
- For postpartum women;
- Those who developed a condition requiring separation from their babies,
- Those who wanted to leave the study during the follow-ups,
- Those who filled out the data collection forms incompletely,
- Those who gave birth before the third interview were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
The study was conducted to determine the effect of continuous midwife support provided to primiparous pregnant women until the postpartum period on comfort, sleep quality and breastfeeding self-sufficiency.
Read the detailed description
The study was conducted to determine the effect of continuous midwifery support provided to primiparous pregnant women until the postpartum period on comfort, sleep quality, and breastfeeding self-efficacy.
Materials and Methods: This randomized controlled trial included a total of 128 pregnant women-64 in the experimental group and 64 in the control group-who were in the 36th week of pregnancy and applied to the Elazığ Palu State Hospital Gynecology and Obstetrics Outpatient Clinic. During the first interview (36th week), pre-test data were collected in the NST room using the "Personal Information Form", "General Comfort Questionnaire", "Pittsburgh Sleep Quality Index", and the "Antenatal Breastfeeding Self-Efficacy Scale-Short Form".
In the second (37th week of pregnancy), third (38th week of pregnancy), and fifth interviews (within the first 4-8 hours postpartum), participants in the experimental group received training in line with educational booklets prepared by the researcher. Since the fourth interview was scheduled during the labor process, continuous support was provided to the pregnant women during childbirth. The sixth interview was conducted between the 5th and 7th days postpartum, during which post-test data were collected using the "General Comfort Questionnaire", "Pittsburgh Sleep Quality Index", and the "Postnatal Breastfeeding Self-Efficacy Scale-Short Form".
- Being tested
- Continuous midwife support care, Pilates ball usage, warm shower
- Keywords
- Breastfeeding self-efficacy, Comfort, Continuous midwifery support, Primiparity, Sleep quality
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous midwife support careOther
Primiparous pregnant women are provided with continuous and individual midwife support starting from the 36th week until the postpartum period.
Pilates ball usageOther
Primiparous pregnant women were provided with educational support starting from the prenatal period to the postnatal period. In addition, depending on the preferences of the pregnant woman, at least one of the above-mentioned practices was chosen with the accompaniment of a midwife at the time of birth.
warm showerOther
It was generally applied to the majority of our pregnant women within the scope of training.
| Study group | Role | What they receive |
|---|---|---|
| Continuous midwife support care | Active comparator | Experimental Group First Interview (36th week of pregnancy - first encounter) Second Interview (37th week of pregnancy) Third Interview (38th week of pregnancy) Fourth Observation (Hospital follow-up covering the labor process and the first day after birth)
Fifth Interview (5-7th day after birth): Receives: Other: Continuous midwife support care; Other: Pilates ball usage; Other: warm shower |
| Control Group | No intervention | Control Group First Interview (36th week of pregnancy - first encounter) Second Interview (5-7th day after birth): |
What is being measured
The primary outcome is the main question the study is designed to answer.
It was determined that continuous midwife support provided to primiparous pregnant women until the postpartum period increased women's comfort, sleep quality and breastfeeding self-sufficiency.
Outcome Measure Title:
General Comfort Level
Description:
General comfort level is assessed using the General Comfort Scale developed by Kolcaba (1992) and validated in Turkish by Kuğuoğlu and Karabacak (2008). This 48-item Likert-type scale includes four subdimensions: Physical Comfort (12 items), Psychospiritual Comfort (13 items), Environmental Comfort (13 items), and Sociocultural Comfort (10 items). Scores are calculated by reverse coding negative items, summing with positive items, and dividing by the number of items to yield an average score ranging from 1 (low comfort) to 4 (high comfort). Reliability coefficients (Cronbach's alpha) in this study were 0.773 (experimental group) and 0.905 (control group).
Measurement Unit:
Mean score (1-4),
Measured: 8 weeks
It was determined that continuous midwife support provided to primiparous pregnant women until the postpartum period increased women's comfort, sleep quality and breastfeeding self-sufficiency.
Title: Sleep Quality Measured by the Pittsburgh Sleep Quality Index (PSQI) Description: Sleep quality was assessed using the PSQI, a validated questionnaire measuring sleep quality over the past month. The scale consists of 19 self-reported items scored from 0 to 3, with total scores ranging from 0 to 21. Scores above 5 indicate poor sleep quality. The study measured the change in PSQI total scores from baseline (pre-intervention) to post-intervention between the experimental and control groups.
Measured: 8 weeks
It was determined that continuous midwife support provided to primiparous pregnant women until the postpartum period increased women's comfort, sleep quality and breastfeeding self-sufficiency.
Title: Breastfeeding Self-Efficacy Measured by the Antenatal Breastfeeding Self-Efficacy Scale - Short Form (AEBS-SF) Description: Breastfeeding self-efficacy was evaluated using the AEBS-SF, a validated 14-item questionnaire with a 5-point Likert scale (1 = Not confident at all, 5 = Always confident). Scores range from 14 to 70, with higher scores indicating greater breastfeeding self-efficacy. The study assessed changes in breastfeeding self-efficacy scores from baseline to post-intervention in the experimental group.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start1 Jan 2024
- Primary completion30 Apr 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of Continuous Midwifery Support on Comfort, Sleep, and Breastfeeding Self-Efficacy in Primiparous Women: A Follow-Up From Pregnancy to MotherhoodStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Palu Devlet Hastanesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sümeyye ŞİMŞEK, Palu Devlet Hastanesi
- Investigators
- Sümeyye ŞİMŞEK, MSC student, Principal investigator, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07165288
- Sponsor's protocol ID
- Palu Devlet Hastanesi
- Status last verified
- Mar 2025
- First submitted
- 8 Mar 2025
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: I think this is a special work. So I am undecided about it.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Continuous Midwifery Support on Comfort, Sleep Quality, and Breastfeeding Self-Efficacy in Primiparous Women: A Follow-Up Study From Pregnancy to Motherhood
- ClinicalTrials.gov ID
- NCT07165288
- Acronym / sponsor ID
- Palu Devlet Hastanesi
- Keywords
- Breastfeeding self-efficacy, Comfort, Continuous midwifery support, Primiparity, Sleep quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Palu Devlet HastanesiUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 10 Sep 2025 (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 study was conducted to determine the effect of continuous midwife support provided to primiparous pregnant women until the postpartum period on comfort, sleep quality and breastfeeding self-sufficiency.
Detailed description
The study was conducted to determine the effect of continuous midwifery support provided to primiparous pregnant women until the postpartum period on comfort, sleep quality, and breastfeeding self-efficacy.
Materials and Methods: This randomized controlled trial included a total of 128 pregnant women-64 in the experimental group and 64 in the control group-who were in the 36th week of pregnancy and applied to the Elazığ Palu State Hospital Gynecology and Obstetrics Outpatient Clinic. During the first interview (36th week), pre-test data were collected in the NST room using the "Personal Information Form", "General Comfort Questionnaire", "Pittsburgh Sleep Quality Index", and the "Antenatal Breastfeeding Self-Efficacy Scale-Short Form".
In the second (37th week of pregnancy), third (38th week of pregnancy), and fifth interviews (within the first 4-8 hours postpartum), participants in the experimental group received training in line with educational booklets prepared by the researcher. Since the fourth interview was scheduled during the labor process, continuous support was provided to the pregnant women during childbirth. The sixth interview was conducted between the 5th and 7th days postpartum, during which post-test data were collected using the "General Comfort Questionnaire", "Pittsburgh Sleep Quality Index", and the "Postnatal Breastfeeding Self-Efficacy Scale-Short Form".
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous midwife support care | Active comparator | Other: Continuous midwife support care, Other: Pilates ball usage, Other: warm showerExperimental Group First Interview (36th week of pregnancy - first encounter) Second Interview (37th week of pregnancy) Third Interview (38th week of pregnancy) Fourth Observation (Hospital follow-up covering the labor process and the first day after birth) Fifth Interview (5-7th day after birth): |
| Control Group | No intervention | –Control Group First Interview (36th week of pregnancy - first encounter) Second Interview (5-7th day after birth): |
Who may qualify
- Ages
- 18 to 36 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- All pregnant women who communicate verbally and do not have a reading or writing disability,
- Having a singleton healthy pregnancy,
- Having a primiparous pregnancy in the 36th week of pregnancy,
- Not a midwife by profession,
- Not having any diagnosed psychiatric problems were included.
Key exclusion criteria (6 listed)
- Women who developed an indication for cesarean section were excluded.
- For postpartum women;
- Those who developed a condition requiring separation from their babies,
- Those who wanted to leave the study during the follow-ups,
- Those who filled out the data collection forms incompletely,
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 |
|---|---|---|
| Continuous midwife support carePrimiparous pregnant women are provided with continuous and individual midwife support starting from the 36th week until the postpartum period. | Other | Continuous midwife support care |
| Pilates ball usagePrimiparous pregnant women were provided with educational support starting from the prenatal period to the postnatal period. In addition, depending on the preferences of the pregnant woman, at least one of the above-mentioned practices was chosen with the accompaniment of a midwife at the time of birth. | Other | Continuous midwife support care |
| warm showerIt was generally applied to the majority of our pregnant women within the scope of training. | Other | Continuous midwife support care |
Primary outcome
It was determined that continuous midwife support provided to primiparous pregnant women until the postpartum period increased women's comfort, sleep quality and breastfeeding self-sufficiency.
Time frame: 8 weeks
Outcome Measure Title: General Comfort Level Description: General comfort level is assessed using the General Comfort Scale developed by Kolcaba (1992) and validated in Turkish by Kuğuoğlu and Karabacak (2008). This 48-item Likert-type scale includes four subdimensions: Physical Comfort (12 items), Psychospiritual Comfort (13 items), Environmental Comfort (13 items), and Sociocultural Comfort (10 items). Scores are calculated by reverse coding negative items, summing with positive items, and dividing by the number of items to yield an average score ranging from 1 (low comfort) to 4 (high comfort). Reliability coefficients (Cronbach's alpha) in this study were 0.773 (experimental group) and 0.905 (control group). Measurement Unit: Mean score (1-4),
It was determined that continuous midwife support provided to primiparous pregnant women until the postpartum period increased women's comfort, sleep quality and breastfeeding self-sufficiency.
Time frame: 8 weeks
Title: Sleep Quality Measured by the Pittsburgh Sleep Quality Index (PSQI) Description: Sleep quality was assessed using the PSQI, a validated questionnaire measuring sleep quality over the past month. The scale consists of 19 self-reported items scored from 0 to 3, with total scores ranging from 0 to 21. Scores above 5 indicate poor sleep quality. The study measured the change in PSQI total scores from baseline (pre-intervention) to post-intervention between the experimental and control groups.
It was determined that continuous midwife support provided to primiparous pregnant women until the postpartum period increased women's comfort, sleep quality and breastfeeding self-sufficiency.
Time frame: 8 weeks
Title: Breastfeeding Self-Efficacy Measured by the Antenatal Breastfeeding Self-Efficacy Scale - Short Form (AEBS-SF) Description: Breastfeeding self-efficacy was evaluated using the AEBS-SF, a validated 14-item questionnaire with a 5-point Likert scale (1 = Not confident at all, 5 = Always confident). Scores range from 14 to 70, with higher scores indicating greater breastfeeding self-efficacy. The study assessed changes in breastfeeding self-efficacy scores from baseline to post-intervention in the experimental group.
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 10 Sep 2025.
- Qualitative study in a maternity unit in Norway, where approximately 4000 births take place each year. In-depth interviews were conducted with ten midwives working in two different maternity units. Qualitative data were analysed using systematic text conLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. I think this is a special work. So I am undecided about it.
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.
Sümeyye ŞİMŞEK, MSC student principal investigator
Inonu 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 Continuous midwife support care, Pilates ball usage and warm shower in people with Effect of Continuous Midwifery Support on Comfort, Sleep, and Breastfeeding Self-Efficacy in Primiparous Women: A Follow-Up From Pregnancy to Motherhood, run by Palu Devlet Hastanesi 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 6 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 10 Sep 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. 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?
It was determined that continuous midwife support provided to primiparous pregnant women until the postpartum period increased women's comfort, sleep quality and breastfeeding self-sufficiency. (time frame: 8 weeks). The study lists 3 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 10 Sep 2025.