AcupressureNCT04589000
The Effect of Acupressure in Non-breastfeeding Mothers After Preterm Cesarean Delivery
A study testing acupressure in people with Acupressure and Breastfeeding, run by Esra SARI at 1 site in Turkey (Türkiye).
Trial summary
The effect of acupressure in non-breastfeeding mothers after preterm cesarean delivery Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Acupressure, Breastfeeding
- What is being tested?
- acupressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Apr 2019to 30 Dec 2020
- 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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Mothers between the ages of 19-35,
- Mothers who gave birth by cesarean operation,
- Mothers who gave birth before 37th week of pregnancy,
- Primiparous mothers,
- Mothers whose baby is lying in NICU,
- Mothers who do not have any chronic diseases,
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- Mothers who do not use breast milk enhancing drugs, vitamins and supplements,
- Mothers who do not have any anotomic disorder in the breast,
- Mothers who cannot breastfeed,
- Mothers who do not have any injured skin, fracture, swelling or muscle pain, especially in the little finger.
- Mothers without literacy problems, mental disabilities and communication problems,
- Mothers living within the borders of the province of Van,
- Mothers who agree to participate in the study.
Who cannot join
- Mothers of premature newborns who cannot be fed breast milk,
- Mothers who are multiparous,
- Mothers with chronic disease,
- Mothers who have a condition preventing milking,
- Mothers whose language is insufficient in understanding and speaking Turkish,
- Mothers who have breast abscess problems,
- Mothers who have babies with congenital anomalies,
- They are mothers who do not volunteer to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Esra Sarı
Van, 65080
esra sarı, 05459027677
About this study
The effect of acupressure in non-breastfeeding mothers after preterm cesarean delivery
Read the detailed description
One of the frequently encountered problems in breastfeeding is insufficient lactation. Numerous integrative treatments support to overcome this problem.
This randomized controlled experimental study will conduct to determine the effect of acupressure on lactation in non-breastfeeding mothers following preterm caesarean delivery.
The sample of the study will comprise of 64 mothers (32 acupressure-experimental and 32 control group), who will randomly select from among the primipara mothers of premature newborns delivered through cesarean section at Dursun Odabaş Medical Center of Van Yüzüncü Yıl University. Before the implementation, the Depression-Anxiety-Stress Scale and the Richard Campbell Sleep Quality Scale will apply. In post-operative three days, 15-minute acupressure will implement in the morning/evening, for acupressure-group mothers and pump milking will apply; control group mothers will only milked in mornings and evenings. Lactation symptoms will evaluate with Visual Analog Scale and acupressure satisfaction with Analog Patient Satisfaction Scale, and milk quantities will record.
- Conditions
- Acupressure, Breastfeeding
- Being tested
- acupressure
- Keywords
- acupressure, breastfeeding
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupressureOther
Throughout the study, acupressure will be applied to the acupressure group once on the post-op day 0, 2 times on the post-op 1st day, and once on the post-op 2nd day, 4 times in total for 15 minutes.
15 minutes after acupressure application, milk will be expressed for 15 minutes and the amount of milk expressed will be recorded in the milk measurement table.
| Study group | Role | What they receive |
|---|---|---|
| acupressure | Experimental | Throughout the study, acupressure will be applied to the acupressure group once on the post-op day 0, 2 times on the post-op 1st day, and once on the post-op 2nd day, 4 times in total for 15 minutes.
15 minutes after acupressure application, milk will be expressed for 15 minutes and the amount of milk expressed will be recorded in the milk measurement table. Receives: Other: acupressure |
| control | No intervention | No accupressure will be applied. Milk will be expressed for a total of 15 minutes, 1 time on the post-op 0th day, 2 times on the post-op 1st day and once on the post-op 2nd day for a total of 15 minutes and will be recorded in the milk measurement table. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the amount of breast milk
The amount of milk will be checked twice a day 15 minutes after acupressure application
Measured: 3 days
Secondary outcomes (2)
The time of onset of the first colostrum and the symptoms of the first milk in mothers
Measured: 3 days
Visual Analogue Satisfaction Patient Scale (VASPS) for Breastfeeding Satisfaction
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start12 Apr 2019
- Primary completion30 Nov 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcupressureStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Esra SARI
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Esra SARI, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04589000
- Sponsor's protocol ID
- ESARI
- Other IDs
- Esra SARI
- Status last verified
- Oct 2020
- First submitted
- 12 Oct 2020
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Acupressure in Non-breastfeeding Mothers After Preterm Cesarean Delivery
- ClinicalTrials.gov ID
- NCT04589000
- Acronym / sponsor ID
- ESARI
- Conditions
- Acupressure, Breastfeeding
- Keywords
- acupressure, breastfeeding
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Esra SARIUniversity, hospital or other
- Study start
- 12 Apr 2019 (actual)
- Primary completion
- 30 Nov 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 19 Oct 2020 (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 effect of acupressure in non-breastfeeding mothers after preterm cesarean delivery
Detailed description
One of the frequently encountered problems in breastfeeding is insufficient lactation. Numerous integrative treatments support to overcome this problem.
This randomized controlled experimental study will conduct to determine the effect of acupressure on lactation in non-breastfeeding mothers following preterm caesarean delivery.
The sample of the study will comprise of 64 mothers (32 acupressure-experimental and 32 control group), who will randomly select from among the primipara mothers of premature newborns delivered through cesarean section at Dursun Odabaş Medical Center of Van Yüzüncü Yıl University. Before the implementation, the Depression-Anxiety-Stress Scale and the Richard Campbell Sleep Quality Scale will apply. In post-operative three days, 15-minute acupressure will implement in the morning/evening, for acupressure-group mothers and pump milking will apply; control group mothers will only milked in mornings and evenings. Lactation symptoms will evaluate with Visual Analog Scale and acupressure satisfaction with Analog Patient Satisfaction Scale, and milk quantities will record.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acupressure | Experimental | Other: acupressureThroughout the study, acupressure will be applied to the acupressure group once on the post-op day 0, 2 times on the post-op 1st day, and once on the post-op 2nd day, 4 times in total for 15 minutes. 15 minutes after acupressure application, milk will be expressed for 15 minutes and the amount of milk expressed will be recorded in the milk measurement table. |
| control | No intervention | –No accupressure will be applied. Milk will be expressed for a total of 15 minutes, 1 time on the post-op 0th day, 2 times on the post-op 1st day and once on the post-op 2nd day for a total of 15 minutes and will be recorded in the milk measurement table. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Mothers between the ages of 19-35,
Key exclusion criteria (8 listed)
- Mothers of premature newborns who cannot be fed breast milk,
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 |
|---|---|---|
| acupressureThroughout the study, acupressure will be applied to the acupressure group once on the post-op day 0, 2 times on the post-op 1st day, and once on the post-op 2nd day, 4 times in total for 15 minutes. 15 minutes after acupressure application, milk will be expressed for 15 minutes and the amount of milk expressed will be recorded in the milk measurement table. | Other | acupressure |
Primary outcome
the amount of breast milk
Time frame: 3 days
The amount of milk will be checked twice a day 15 minutes after acupressure application
2 secondary outcomes
The time of onset of the first colostrum and the symptoms of the first milk in mothers
Time frame: 3 days
Visual Analogue Satisfaction Patient Scale (VASPS) for Breastfeeding Satisfaction
Time frame: 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupressure in people with Acupressure and Breastfeeding, run by Esra SARI 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 13 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 19 Oct 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact esra sarı (05459027677, esrasari@yyu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the amount of breast milk (time frame: 3 days). 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 19 Oct 2020.