Pregnancy RelatedNCT06325839
Effects of HypnoBirthing Training and Oxytocin Massage in Primiparous Pregnants
A study testing HypnoBirthing training and oxytocin massage group in people with Pregnancy Related, run by Giresun University at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted to determine the effects of hypnobirthing training and oxytocin massage on birth and postpartum period in primiparous pregnant women. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- HypnoBirthing training and oxytocin massage group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2023to 10 Sep 2023
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women between the ages of 18 and 45,
- Able to communicate verbally,
- Being in the 36th week of pregnancy,
- Having a single fetus,
- Being nulliparous
Who cannot join
- Pregnant women at risk
- Multiparous pregnant women
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Giresun Gynecology and Children's Diseases Hospital
Giresun, Center, 28200
About this study
Official title: Effects of HypnoBirthing Training and Oxytocin Massage on Delivery and Postpartum Period in Primiparous Pregnants: A Randomized Controlled Study
This study was conducted to determine the effects of hypnobirthing training and oxytocin massage on birth and postpartum period in primiparous pregnant women.
Read the detailed description
Hypnobirthing is a birth philosophy and method that prepares women physically and psychologically for giving birth. It is important to break the fear-tension-pain cycle in HypnoBirthing training. Because the continuity of the cycle increases the pain related to birth, and as the pain increases, the fear increases. In this case, the duration of labor is prolonged, birth success, shape, preference, course and satisfaction are negatively affected. Therefore, this training helps to reduce pain and fear related to labor and increase labor satisfaction. Similarly, it has been determined in the literature that oxytocin (back massage) massage during pregnancy increases uterine contractions, reduces labor pain and duration of labor, accelerates postpartum uterine involution, significantly increases the amount of breast milk, and increases mother-baby attachment. The pregnant education role of the health professional is an effective factor that shapes the birth experience of pregnant women. For this purpose, health professionals in the world and in our country are actively involved in pregnancy education programs in which different methods are applied. The most common ones are Lamaze, Bradly and HypnoBirthing. These trainings also serve to reduce pain and fear related to childbirth, increase labor and postpartum satisfaction, and meet the need for professional support and education of pregnant women. When the studies on HypnoBirthing training and oxytocin massage are examined in the literature, it is noteworthy that there is a very limited number of studies. Therefore, there is a need for well-designed randomized controlled trials that can create a level of evidence for HypnoBirthing training and oxytocin massage.
- Conditions
- Pregnancy Related
- Being tested
- HypnoBirthing training and oxytocin massage group
- Keywords
- Pregnancy, Birth, oxytocin, postpartum, hypno-birthing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypnoBirthing training and oxytocin massage groupOther
HypnoBirthing training and oxytocin massage were applied for a total of 12 hours for 4 weeks with the experimental group.
| Study group | Role | What they receive |
|---|---|---|
| HypnoBirthing training and oxytocin massage group | Experimental | Pregnant women who received HypnoBirthing training and oxytocin massage constituted the experimental group. Receives: Other: HypnoBirthing training and oxytocin massage group |
| The group without HypnoBirthing training and oxytocin massage | No intervention | Pregnant women who did not receive HypnoBirthing training and oxytocin massage constituted the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wijma Birth Anticipation/Experience Scale A (W-DEQ-A)
The WDEQ A is a six-point Likert-type scale consisting of 33 items, scored 0-5, with 0 being "completely" and 5 being "not at all". The pregnant woman is asked to indicate a number between 0 and 5 that suits her. W-DEQ-A scores were categorized into four subgroups. These are women with a low degree of fear of childbirth (W-DEQ-A score ≤37), women with moderate fear of childbirth (W-DEQ-A score between 38-65), women with severe fear of childbirth (W-DEQ-A score 66-84) and women with clinical fear of childbirth (W-DEQ-A score ≥ 85).
Measured: five weeks
Secondary outcomes (4)
Wijma Birth Expectancy/Expectation Scale B (W-DEQ-B)
The scale consists of 33 items. The responses in the scale are numbered from 0 to 5 and are in six-point Likert type. 0 means "completely" and 5 means "not at all". The minimum score on the scale is 0, while the maximum score is 160. As the score increases, the fear of childbirth experienced by women increases.
Measured: Five weeks
Postpartum Breastfeeding Self-Efficacy Scale - Short Form
The scale consists of 14 items. The scale is a 5-point Likert scale, ranging from never sure (1 point) to always sure (5 points). The minimum score is 14 and the maximum score is 70. The scale has no cut-off point and a higher score means higher breastfeeding self-efficacy.
Measured: 5 weeks
Mother-Infant Attachment Scale (MICS)
This scale, consisting of 8 items, is designed to be applied from the first day after birth and allows the mother to express her feelings towards her baby with a single word. It is a 4-point Likert scale. Responses consisting of four options are scored between 0-3, the lowest score that can be obtained from the scale is 0 and the highest score is 24. High scores indicate that mother-baby attachment is strong.
Measured: 5 weeks
Birth satisfaction scale short form (BSS-SF)
BSS-SF is a 10-item scale of 5-point Likert type. The lowest score from the scale is "0" and the highest score is "40", and as the score obtained from the scale increases, the level of satisfaction increases.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start1 Apr 2023
- Primary completion10 Sep 2023
- Study completion10 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies 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
- Model description
- The research is an experimental study with a randomized control group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Giresun University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ezgi.sahin, Giresun University
- Investigators
- Ezgi ŞAHİN, ph.D, Principal investigator, Giresun University Faculty of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06325839
- Sponsor's protocol ID
- GRU-SBF-ES-01
- Status last verified
- Mar 2024
- First submitted
- 16 Mar 2024
- Last updated
- 22 Mar 2024
- 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 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of HypnoBirthing Training and Oxytocin Massage on Delivery and Postpartum Period in Primiparous Pregnants: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06325839
- Acronym / sponsor ID
- GRU-SBF-ES-01
- Conditions
- Pregnancy Related
- Keywords
- Pregnancy, Birth, oxytocin, postpartum, hypno-birthing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Giresun UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 10 Sep 2023 (actual)
- Study completion
- 10 Sep 2023 (actual)
- First posted
- 22 Mar 2024 (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.
This study was conducted to determine the effects of hypnobirthing training and oxytocin massage on birth and postpartum period in primiparous pregnant women.
Detailed description
Hypnobirthing is a birth philosophy and method that prepares women physically and psychologically for giving birth. It is important to break the fear-tension-pain cycle in HypnoBirthing training. Because the continuity of the cycle increases the pain related to birth, and as the pain increases, the fear increases. In this case, the duration of labor is prolonged, birth success, shape, preference, course and satisfaction are negatively affected. Therefore, this training helps to reduce pain and fear related to labor and increase labor satisfaction. Similarly, it has been determined in the literature that oxytocin (back massage) massage during pregnancy increases uterine contractions, reduces labor pain and duration of labor, accelerates postpartum uterine involution, significantly increases the amount of breast milk, and increases mother-baby attachment. The pregnant education role of the health professional is an effective factor that shapes the birth experience of pregnant women. For this purpose, health professionals in the world and in our country are actively involved in pregnancy education programs in which different methods are applied. The most common ones are Lamaze, Bradly and HypnoBirthing. These trainings also serve to reduce pain and fear related to childbirth, increase labor and postpartum satisfaction, and meet the need for professional support and education of pregnant women. When the studies on HypnoBirthing training and oxytocin massage are examined in the literature, it is noteworthy that there is a very limited number of studies. Therefore, there is a need for well-designed randomized controlled trials that can create a level of evidence for HypnoBirthing training and oxytocin massage.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The research is an experimental study with a randomized control group.
| Arm | Type | Receives |
|---|---|---|
| HypnoBirthing training and oxytocin massage group | Experimental | Other: HypnoBirthing training and oxytocin massage groupPregnant women who received HypnoBirthing training and oxytocin massage constituted the experimental group. |
| The group without HypnoBirthing training and oxytocin massage | No intervention | –Pregnant women who did not receive HypnoBirthing training and oxytocin massage constituted the control group. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Pregnant women between the ages of 18 and 45,
- Able to communicate verbally,
- Being in the 36th week of pregnancy,
- Having a single fetus,
- Being nulliparous
Key exclusion criteria (2 listed)
- Pregnant women at risk
- Multiparous pregnant women
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 |
|---|---|---|
| HypnoBirthing training and oxytocin massage groupHypnoBirthing training and oxytocin massage were applied for a total of 12 hours for 4 weeks with the experimental group. | Other | HypnoBirthing training and oxytocin massage group |
Primary outcome
Wijma Birth Anticipation/Experience Scale A (W-DEQ-A)
Time frame: five weeks
The WDEQ A is a six-point Likert-type scale consisting of 33 items, scored 0-5, with 0 being "completely" and 5 being "not at all". The pregnant woman is asked to indicate a number between 0 and 5 that suits her. W-DEQ-A scores were categorized into four subgroups. These are women with a low degree of fear of childbirth (W-DEQ-A score ≤37), women with moderate fear of childbirth (W-DEQ-A score between 38-65), women with severe fear of childbirth (W-DEQ-A score 66-84) and women with clinical fear of childbirth (W-DEQ-A score ≥ 85).
4 secondary outcomes
Wijma Birth Expectancy/Expectation Scale B (W-DEQ-B)
Time frame: Five weeks
Postpartum Breastfeeding Self-Efficacy Scale - Short Form
Time frame: 5 weeks
Mother-Infant Attachment Scale (MICS)
Time frame: 5 weeks
Birth satisfaction scale short form (BSS-SF)
Time frame: 5 weeks
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 22 Mar 2024.
- 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.
Ezgi ŞAHİN, ph.D principal investigator
Giresun University Faculty of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HypnoBirthing training and oxytocin massage group in people with Pregnancy Related, run by Giresun 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 5 inclusion and 2 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 22 Mar 2024. 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?
Wijma Birth Anticipation/Experience Scale A (W-DEQ-A) (time frame: five weeks). 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 22 Mar 2024.