Breastfeeding, ExclusivepostpartumNCT06628986
MBSR and NLP, Postpartum Breastfeeding and Depression
A study testing MBSR and NLP in people with Breastfeeding, Exclusive and Fatigue, run by Aysegul Kilicli at 1 site in Turkey (Türkiye).
Trial summary
The postnatal period is a risky period in which mothers experience regressive and progressive changes and rapid biopsychosocial changes. Since this process affects not only the mother but also the family, mothers are under intense stress due to adaptation to the changes that occur in this period. Read more about this study
- Who is it for?
- Ages 19 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding, Exclusive, Fatigue, Sleep
- What is being tested?
- MBSR and NLP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Oct 2024to 30 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 19-35 years old
- caesarean section
- primiparous
- breastfeeding women
Who cannot join
- women who refused to participate in the research.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Şanlıurfa training and research hospital
Sanliurfa, Eyalet/Yerleşke, 63000
AYŞEGÜL KILIÇLI, 04143186000, aysegul_ay_9@hotmail.com
About this study
Official title: the Effect of MBSR and NLP Applications on Fatigue, Sleep Quality, Lactation and Postpartum Depression in the Postpartum Period After Caesarean Section
The postnatal period is a risky period in which mothers experience regressive and progressive changes and rapid biopsychosocial changes. Since this process affects not only the mother but also the family, mothers are under intense stress due to adaptation to the changes that occur in this period.
Read the detailed description
The postnatal period is a risky period in which retrogressive and progressive changes and rapid biopsychosocial changes occur in mothers. Since this process affects not only the mother but also the family, mothers are under intense stress due to adaptation to the changes occurring in this period. Studies have reported that the most common physical problems in the early postpartum period after caesarean section are pain in the incision area, difficulty in caring for the baby alone, activity intolerance, fatigue, insomnia, breastfeeding problems (such as nipple or lack of milk), mastitis and abdominal tension/gas. As important as it is to reduce postpartum symptoms after caesarean section, it is also important to support and maintain breastfeeding. However, postpartum symptoms such as pain, fatigue and negative effects of anaesthesia after caesarean section negatively affect the breastfeeding process and lead to a delay in the onset of lactation.
When the literature was examined, no study was found that examined the effects of mindfulness-based stress reduction programme and neurolinguistic programme on fatigue, sleep quality, lactation and depression in the postpartum long term.
- Conditions
- Breastfeeding, Exclusive, Fatigue, Sleep, Postpartum Depression
- Being tested
- MBSR, NLP, control
- Keywords
- breastfeeding, fatigue, sleep, postpartum depression
- Medical subject headings
- Breast Feeding, Fatigue, Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBSRBehavioural
Also called MBSR mindfulness-based stress reduction program
20 minutes once a week for 8 weeks
NLPBehavioural
Also called NLP Neurolinguistic programming
NLP Neurolinguistic programming, 20 minutes once a week for 8 weeks
controlBehavioural
Also called control group
control group, no practice,
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-based stress reduction program | Experimental | MBSR; Mindfulness-based stress reduction program. 8 weeks of practice once a week for 20 minutes each. Mindfulness-based stress reduction practices will be carried out online. Mothers will actively participate. Receives: Behavioral: MBSR |
| Neurolinguistic programming | Experimental | NLP; Neurolinguistic programming 8 weeks of practice once a week for 20 minutes each. Neurolinguistic programming will be carried out online. Mothers will actively participate. Receives: Behavioral: NLP |
| control | Experimental | control; MBSR and NLP applications will not be performed. Mothers will be monitored online every week. Receives: Behavioral: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale for Fatigue (VAS-F)
Visual Analogue Scale for Fatigue (VAS-F), The most positive expression of the fatigue sub-dimension is 0 and the most negative expression is 10, the most negative expression of the energy sub-dimension is 0 and the most positive expression is 10.
Measured: before the first application
Visual Analogue Scale for Fatigue (VAS-F)
Visual Analogue Scale for Fatigue (VAS-F) The most positive expression of the fatigue sub-dimension is 0 and the most negative expression is 10, the most negative expression of the energy sub-dimension is 0 and the most positive expression is 10.
Measured: Week 4
Visual Analogue Scale for Fatigue (VAS-F)
Visual Analogue Scale for Fatigue (VAS-F) The most positive expression of the fatigue sub-dimension is 0 and the most negative expression is 10, the most negative expression of the energy sub-dimension is 0 and the most positive expression is 10.
Measured: Week 8
Pittsburgh Sleep Quality Index (PSQI)
Pittsburgh Sleep Quality Index (PSQI) Each item is evaluated as 0-3 points and the sum of the 7 subcomponents constitutes the PDQI score. The lowest score of the scale is 0 and the highest score is 21. A total PDQI score of ≤5 indicates good sleep and >5 indicates poor sleep.
Measured: before the first application
Pittsburgh Sleep Quality Index (PSQI)
Pittsburgh Sleep Quality Index (PSQI) Each item is evaluated as 0-3 points and the sum of the 7 subcomponents constitutes the PDQI score. The lowest score of the scale is 0 and the highest score is 21. A total PDQI score of ≤5 indicates good sleep and >5 indicates poor sleep.
Measured: week 4
Pittsburgh Sleep Quality Index (PSQI)
Pittsburgh Sleep Quality Index (PSQI) Each item is evaluated as 0-3 points and the sum of the 7 subcomponents constitutes the PDQI score. The lowest score of the scale is 0 and the highest score is 21. A total PDQI score of ≤5 indicates good sleep and >5 indicates poor sleep.
Measured: week 8
Bristol Breastfeeding Assessment Tool (BBAT)
Bristol Breastfeeding Assessment Tool (BBAT) In the scoring of the scale, each item is between 0-2 points. The calculation method is to sum all the scores obtained from the scale items. The lowest score obtained from the scale is 0 and the highest score is 8. The scale does not have a cut-off point. A low score indicates that breastfeeding is not effective and a high score indicates that breastfeeding is effective.
Measured: before the first application
Bristol Breastfeeding Assessment Tool (BBAT)
Bristol Breastfeeding Assessment Tool (BBAT) In the scoring of the scale, each item is between 0-2 points. The calculation method is to sum all the scores obtained from the scale items. The lowest score obtained from the scale is 0 and the highest score is 8. The scale does not have a cut-off point. A low score indicates that breastfeeding is not effective and a high score indicates that breastfeeding is effective.
Measured: week 4
Bristol Breastfeeding Assessment Tool (BBAT)
Bristol Breastfeeding Assessment Tool (BBAT) In the scoring of the scale, each item is between 0-2 points. The calculation method is to sum all the scores obtained from the scale items. The lowest score obtained from the scale is 0 and the highest score is 8. The scale does not have a cut-off point. A low score indicates that breastfeeding is not effective and a high score indicates that breastfeeding is effective.
Measured: week 8
Edinburgh Postpartum Depression Scale (EPDS)
Edinburgh Postpartum Depression Scale (EPDS) The scale is a 4-point Likert-type scale consisting of 10 items. Responses consisting of four options are scored between 0 and 3. A minimum of 0 and a maximum of 30 points can be obtained from the scale. The cut-off point of the scale is 13 points and above for women and 10 points and above for men, and above this point indicates the presence of depression.
Measured: before the first application
Edinburgh Postpartum Depression Scale (EPDS)
Edinburgh Postpartum Depression Scale (EPDS) The scale is a 4-point Likert-type scale consisting of 10 items. Responses consisting of four options are scored between 0 and 3. A minimum of 0 and a maximum of 30 points can be obtained from the scale. The cut-off point of the scale is 13 points and above for women and 10 points and above for men, and above this point indicates the presence of depression.
Measured: week 4
Edinburgh Postpartum Depression Scale (EPDS)
Edinburgh Postpartum Depression Scale (EPDS) The scale is a 4-point Likert-type scale consisting of 10 items. Responses consisting of four options are scored between 0 and 3. A minimum of 0 and a maximum of 30 points can be obtained from the scale. The cut-off point of the scale is 13 points and above for women and 10 points and above for men, and above this point indicates the presence of depression.
Measured: week 8
Breastfeeding Self-Efficacy Scale (BSES)
Breastfeeding Self-Efficacy Scale (BSES) The scale consists of 14 items, five-point Likert type. The items of the scale are evaluated on a scale from '1=never sure' to 5=always sure'. A minimum of 14 points and a maximum of 70 points can be obtained from the scale. All items are positive. The higher the score obtained from the scale, the higher the breastfeeding self-efficacy.
Measured: before the first application
Breastfeeding Self-Efficacy Scale (BSES)
Breastfeeding Self-Efficacy Scale (BSES) The scale consists of 14 items, five-point Likert type. The items of the scale are evaluated on a scale from '1=never sure' to 5=always sure'. A minimum of 14 points and a maximum of 70 points can be obtained from the scale. All items are positive. The higher the score obtained from the scale, the higher the breastfeeding self-efficacy.
Measured: week 4
Breastfeeding Self-Efficacy Scale (BSES)
Breastfeeding Self-Efficacy Scale (BSES) The scale consists of 14 items, five-point Likert type. The items of the scale are evaluated on a scale from '1=never sure' to 5=always sure'. A minimum of 14 points and a maximum of 70 points can be obtained from the scale. All items are positive. The higher the score obtained from the scale, the higher the breastfeeding self-efficacy.
Measured: week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start8 Oct 2024
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breastfeeding, ExclusiveStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aysegul Kilicli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aysegul Kilicli, University of Gaziantep
- Investigators
- AYŞEGÜL KILIÇLI, Dr., Study director, Muş Alparslan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06628986
- Sponsor's protocol ID
- Mauniv
- Acronym
- postpartum
- Status last verified
- Oct 2024
- First submitted
- 3 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Effect of MBSR and NLP Applications on Fatigue, Sleep Quality, Lactation and Postpartum Depression in the Postpartum Period After Caesarean Section
- ClinicalTrials.gov ID
- NCT06628986
- Acronym / sponsor ID
- postpartum / Mauniv
- Conditions
- Breastfeeding, Exclusive, Fatigue, Sleep, Postpartum Depression
- Keywords
- breastfeeding, fatigue, sleep, postpartum depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Aysegul KilicliUniversity, hospital or other
- Study start
- 8 Oct 2024 (actual)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 8 Oct 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.
The postnatal period is a risky period in which mothers experience regressive and progressive changes and rapid biopsychosocial changes. Since this process affects not only the mother but also the family, mothers are under intense stress due to adaptation to the changes that occur in this period.
Detailed description
The postnatal period is a risky period in which retrogressive and progressive changes and rapid biopsychosocial changes occur in mothers. Since this process affects not only the mother but also the family, mothers are under intense stress due to adaptation to the changes occurring in this period. Studies have reported that the most common physical problems in the early postpartum period after caesarean section are pain in the incision area, difficulty in caring for the baby alone, activity intolerance, fatigue, insomnia, breastfeeding problems (such as nipple or lack of milk), mastitis and abdominal tension/gas. As important as it is to reduce postpartum symptoms after caesarean section, it is also important to support and maintain breastfeeding. However, postpartum symptoms such as pain, fatigue and negative effects of anaesthesia after caesarean section negatively affect the breastfeeding process and lead to a delay in the onset of lactation.
When the literature was examined, no study was found that examined the effects of mindfulness-based stress reduction programme and neurolinguistic programme on fatigue, sleep quality, lactation and depression in the postpartum long term.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-based stress reduction program | Experimental | Behavioral: MBSRMBSR; Mindfulness-based stress reduction program. 8 weeks of practice once a week for 20 minutes each. Mindfulness-based stress reduction practices will be carried out online. Mothers will actively participate. |
| Neurolinguistic programming | Experimental | Behavioral: NLPNLP; Neurolinguistic programming 8 weeks of practice once a week for 20 minutes each. Neurolinguistic programming will be carried out online. Mothers will actively participate. |
| control | Experimental | Behavioral: controlcontrol; MBSR and NLP applications will not be performed. Mothers will be monitored online every week. |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 19-35 years old
- caesarean section
- primiparous
- breastfeeding women
Key exclusion criteria (1 listed)
- women who refused to participate in the research.
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 |
|---|---|---|
| MBSRAlso: MBSR mindfulness-based stress reduction program20 minutes once a week for 8 weeks | Behavioural | Mindfulness-based stress reduction program |
| NLPAlso: NLP Neurolinguistic programmingNLP Neurolinguistic programming, 20 minutes once a week for 8 weeks | Behavioural | Neurolinguistic programming |
| controlAlso: control groupcontrol group, no practice, | Behavioural | control |
Primary outcome
Visual Analogue Scale for Fatigue (VAS-F)
Time frame: before the first application
Visual Analogue Scale for Fatigue (VAS-F), The most positive expression of the fatigue sub-dimension is 0 and the most negative expression is 10, the most negative expression of the energy sub-dimension is 0 and the most positive expression is 10.
Visual Analogue Scale for Fatigue (VAS-F)
Time frame: Week 4
Visual Analogue Scale for Fatigue (VAS-F) The most positive expression of the fatigue sub-dimension is 0 and the most negative expression is 10, the most negative expression of the energy sub-dimension is 0 and the most positive expression is 10.
Visual Analogue Scale for Fatigue (VAS-F)
Time frame: Week 8
Visual Analogue Scale for Fatigue (VAS-F) The most positive expression of the fatigue sub-dimension is 0 and the most negative expression is 10, the most negative expression of the energy sub-dimension is 0 and the most positive expression is 10.
Pittsburgh Sleep Quality Index (PSQI)
Time frame: before the first application
Pittsburgh Sleep Quality Index (PSQI) Each item is evaluated as 0-3 points and the sum of the 7 subcomponents constitutes the PDQI score. The lowest score of the scale is 0 and the highest score is 21. A total PDQI score of ≤5 indicates good sleep and >5 indicates poor sleep.
Pittsburgh Sleep Quality Index (PSQI)
Time frame: week 4
Pittsburgh Sleep Quality Index (PSQI) Each item is evaluated as 0-3 points and the sum of the 7 subcomponents constitutes the PDQI score. The lowest score of the scale is 0 and the highest score is 21. A total PDQI score of ≤5 indicates good sleep and >5 indicates poor sleep.
Pittsburgh Sleep Quality Index (PSQI)
Time frame: week 8
Pittsburgh Sleep Quality Index (PSQI) Each item is evaluated as 0-3 points and the sum of the 7 subcomponents constitutes the PDQI score. The lowest score of the scale is 0 and the highest score is 21. A total PDQI score of ≤5 indicates good sleep and >5 indicates poor sleep.
Bristol Breastfeeding Assessment Tool (BBAT)
Time frame: before the first application
Bristol Breastfeeding Assessment Tool (BBAT) In the scoring of the scale, each item is between 0-2 points. The calculation method is to sum all the scores obtained from the scale items. The lowest score obtained from the scale is 0 and the highest score is 8. The scale does not have a cut-off point. A low score indicates that breastfeeding is not effective and a high score indicates that breastfeeding is effective.
Bristol Breastfeeding Assessment Tool (BBAT)
Time frame: week 4
Bristol Breastfeeding Assessment Tool (BBAT) In the scoring of the scale, each item is between 0-2 points. The calculation method is to sum all the scores obtained from the scale items. The lowest score obtained from the scale is 0 and the highest score is 8. The scale does not have a cut-off point. A low score indicates that breastfeeding is not effective and a high score indicates that breastfeeding is effective.
Bristol Breastfeeding Assessment Tool (BBAT)
Time frame: week 8
Bristol Breastfeeding Assessment Tool (BBAT) In the scoring of the scale, each item is between 0-2 points. The calculation method is to sum all the scores obtained from the scale items. The lowest score obtained from the scale is 0 and the highest score is 8. The scale does not have a cut-off point. A low score indicates that breastfeeding is not effective and a high score indicates that breastfeeding is effective.
Edinburgh Postpartum Depression Scale (EPDS)
Time frame: before the first application
Edinburgh Postpartum Depression Scale (EPDS) The scale is a 4-point Likert-type scale consisting of 10 items. Responses consisting of four options are scored between 0 and 3. A minimum of 0 and a maximum of 30 points can be obtained from the scale. The cut-off point of the scale is 13 points and above for women and 10 points and above for men, and above this point indicates the presence of depression.
Edinburgh Postpartum Depression Scale (EPDS)
Time frame: week 4
Edinburgh Postpartum Depression Scale (EPDS) The scale is a 4-point Likert-type scale consisting of 10 items. Responses consisting of four options are scored between 0 and 3. A minimum of 0 and a maximum of 30 points can be obtained from the scale. The cut-off point of the scale is 13 points and above for women and 10 points and above for men, and above this point indicates the presence of depression.
Edinburgh Postpartum Depression Scale (EPDS)
Time frame: week 8
Edinburgh Postpartum Depression Scale (EPDS) The scale is a 4-point Likert-type scale consisting of 10 items. Responses consisting of four options are scored between 0 and 3. A minimum of 0 and a maximum of 30 points can be obtained from the scale. The cut-off point of the scale is 13 points and above for women and 10 points and above for men, and above this point indicates the presence of depression.
Breastfeeding Self-Efficacy Scale (BSES)
Time frame: before the first application
Breastfeeding Self-Efficacy Scale (BSES) The scale consists of 14 items, five-point Likert type. The items of the scale are evaluated on a scale from '1=never sure' to 5=always sure'. A minimum of 14 points and a maximum of 70 points can be obtained from the scale. All items are positive. The higher the score obtained from the scale, the higher the breastfeeding self-efficacy.
Breastfeeding Self-Efficacy Scale (BSES)
Time frame: week 4
Breastfeeding Self-Efficacy Scale (BSES) The scale consists of 14 items, five-point Likert type. The items of the scale are evaluated on a scale from '1=never sure' to 5=always sure'. A minimum of 14 points and a maximum of 70 points can be obtained from the scale. All items are positive. The higher the score obtained from the scale, the higher the breastfeeding self-efficacy.
Breastfeeding Self-Efficacy Scale (BSES)
Time frame: week 8
Breastfeeding Self-Efficacy Scale (BSES) The scale consists of 14 items, five-point Likert type. The items of the scale are evaluated on a scale from '1=never sure' to 5=always sure'. A minimum of 14 points and a maximum of 70 points can be obtained from the scale. All items are positive. The higher the score obtained from the scale, the higher the breastfeeding self-efficacy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: Yes. All
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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.
AYŞEGÜL KILIÇLI, Dr. study director
Muş Alparslan 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 MBSR and NLP in people with Breastfeeding, Exclusive and Fatigue, run by Aysegul Kilicli 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 4 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 15 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AYŞEGÜL KILIÇLI, Dr. (04143181717, aysegul_ay_9@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale for Fatigue (VAS-F) (time frame: before the first application). The study lists 15 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 15 Oct 2024.