NEUROLINGUISTIC PROGRAMMINGNCT06070792
Neurolinguistic Programming, Progressive Muscle Relaxation Exercises, and Breastfeeding
A study testing NEURO LINGUISTIC PROGRAM and PROGRESSIVE MUSCLE RELAXATION EXERCISES in people with NEUROLINGUISTIC PROGRAMMING and PROGRESSIVE MUSCLE RELAXATION EXERCISES, run by Aysegul Kilicli at 1 site in Turkey (Türkiye).
Trial summary
The effect of neuro linguistic program and progressive muscle relaxation exercises on breastfeeding success and breastfeeding self-efficacy after caesarean section. 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
- NEUROLINGUISTIC PROGRAMMING, PROGRESSIVE MUSCLE RELAXATION EXERCISES, CAESAREAN SECTION
- What is being tested?
- NEURO LINGUISTIC PROGRAM and PROGRESSIVE MUSCLE RELAXATION EXERCISES
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2023to 18 Dec 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 19 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- women who gave birth by caesarean section,
- primiparous,
- who are 19 years of age or older and 35 years of age or younger,
- who were born at 37 or more weeks of gestation,
- who had a singleton birth,
- whose caesarean section operation was performed with spinal anaesthesia,
- who do not have chronic diseases and any breast-related health problems .
Who cannot join
- mothers who did not meet the inclusion criteria,
- who wanted to leave the study voluntarily at any stage after being included in the study,
- who developed any health problems in themselves or their infants were excluded.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Şanlıurfa training and research hospital
Sanliurfa, Eyalet/Yerleşke, 63000
About this study
Official title: The Effect of Neuro Linguistic Program and Progressive Muscle Relaxation Exercises on Breastfeeding Success and Breastfeeding Self-efficacy After Caesarean Section
The effect of neuro linguistic program and progressive muscle relaxation exercises on breastfeeding success and breastfeeding self-efficacy after caesarean section.
Read the detailed description
In this research, it is aimed to detemine the effect of neuro linguistic program and progressive muscle relaxation exercises on breastfeeding success and breastfeeding self-efficacy after caesarean section.
Sample size:
- There will be three groups in the study (two experimental groups and one control group).
- The sample size of the study is 99 people. The sample size will be divided into three and 33 people will be randomly assigned to each group.
- Experiment 1 group: neuro linguistic programme (NLP) group.
- Experiment 2 group: progressive muscle relaxation exercises (PMRE) group.
- Control group: non-intervention group
Data Collection Tools;
- Introductory Information Form,
- Breastfeeding Self-Efficacy Scale,
- Breastfeeding Charting System (LATCH)
Application time:
- NLP and PMRE interventions will be started at the sixth postoperative hour after caesarean section.
- Mothers who give birth by caesarean section are followed up in hospital for 48 hours and mothers are then discharged when their health condition improves. Therefore, data will be collected within 48 hours after caesarean section.
- NLP and PMRE groups will be started at the sixth postoperative hour, 3 times in 24 hours on the first day, 3 times in 24 hours on the second day, six times in total.
- Only NLP and PMRE will not be applied to the control group.
- Care and follow-up will be performed in parallel with the individuals in the experimental group.
Measurement time:
- Mothers will fill in the Introductory Information Form, Breastfeeding Self-Efficacy Scale, Breastfeeding Diagnosis and Assessment Measurement Tool (LATCH) before the application at the sixth postoperative hour.
- Then, in the first 24 hours, the necessary application will be performed once every eight hours according to the groups (for example, NLP application for experiment 1).
- At the end of 24th hour, Breastfeeding Self-Efficacy Scale and Breastfeeding Diagnosis and Assessment Measurement Tool (LATCH) will be completed.
- Then, in the second 24 hours, the interventions will be repeated once every eight hours.
- The total number of application sessions is six.
- NLP application will last 20 minutes each session and PMRE application will last 20 minutes each session.
- Being tested
- NEURO LINGUISTIC PROGRAM, PROGRESSIVE MUSCLE RELAXATION EXERCISES
- Keywords
- NEURO LINGUISTIC PROGRAM, PROGRESSIVE MUSCLE RELAXATION EXERCISES, CAESAREAN SECTION, BREASTFEEDING SUCCESS, BREASTFEEDING SELF-EFFICACY
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEURO LINGUISTIC PROGRAMOther
NEURO LINGUISTIC PROGRAM
PROGRESSIVE MUSCLE RELAXATION EXERCISESOther
PROGRESSIVE MUSCLE RELAXATION EXERCISES
| Study group | Role | What they receive |
|---|---|---|
| NEURO LINGUISTIC PROGRAM | Experimental | first experimental group. It will be administered to primiparous mothers after caesarean section in the first 48 hours after the sixth postoperative hour, once every eight hours, for a total of six times. Each session will last 20 minutes.
In the NLP application; firstly, the most frequently used visual, auditory and/or tactile representation system of the woman will be determined. Then, the internal and external reactions caused by the symptoms after caesarean section, her feelings and thoughts about her baby and breastfeeding will be combined with the anchoring technique. Then, with the swish technique, the existing negative emotions will be reduced and tried to be deleted from the most frequently used representation system. The woman's negative thoughts about breastfeeding will be changed in a positive direction with the belief change model. Receives: Other: NEURO LINGUISTIC PROGRAM |
| PROGRESSIVE MUSCLE RELAXATION EXERCISES | Experimental | second experimental group. It will be administered to primiparous mothers after caesarean section in the first 48 hours after the sixth postoperative hour, once every eight hours, for a total of six times. Each session will last 20 minutes.
PMRE; All muscles of the body will be tried to be relaxed respectively with the commands given gradually. Receives: Other: PROGRESSIVE MUSCLE RELAXATION EXERCISES |
| control | No intervention | The control group will not receive NLP or PMRE. |
What is being measured
The primary outcome is the main question the study is designed to answer.
BREASTFEEDING SUCCESS
Breastfeeding Charting System (LATCH); The measurement tool has no cut-off point, and as the LATCH score increases, it is understood that the process is high. The maximum score that can be obtained is 10. The sum of lower scores indicates that the mother is dependent on help.
Measured: immediately before the first application
BREASTFEEDING SUCCESS
Breastfeeding Charting System (LATCH)
Measured: immediately after the third application (at the 24th hour after the first application)
BREASTFEEDING SUCCESS
Breastfeeding Charting System (LATCH)
Measured: immediately after the sixth application (at the 48th hour after the first application)
BREASTFEEDING SELF-EFFICACY
Breastfeeding Self-Efficacy Scale; A minimum of 14 points and a maximum of 70 points can be obtained from the scale. All are positive elements. The higher the score from the scale, the higher breastfeeding self-efficacy will be achieved.
Measured: immediately before the first application
BREASTFEEDING SELF-EFFICACY
Breastfeeding Self-Efficacy Scale
Measured: immediately after the third application (at the 24th hour after the first application)
BREASTFEEDING SELF-EFFICACY
Breastfeeding Self-Efficacy Scale
Measured: immediately after the sixth application (at the 48th hour after the first application)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start1 Oct 2023
- Primary completion18 Dec 2023
- Study completion18 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NEUROLINGUISTIC PROGRAMMINGStudies 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
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aysegul Kilicli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aysegul Kilicli, University of Gaziantep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06070792
- Sponsor's protocol ID
- NLP, PMRE, AND BREASTFEEDING
- Status last verified
- Sep 2024
- First submitted
- 19 Sep 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kilicli A, Gul S. The effect of neurolinguistic programming and progressive muscle relaxation exercises on breastfeeding success and breastfeeding self-efficacy: A randomized controlled trial. Explore (NY). 2024 Sep-Oct;20(5):103027. doi: 10.1016/j.explore.2024.103027. Epub 2024 Jul 2.
PubMed 39003935
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Neuro Linguistic Program and Progressive Muscle Relaxation Exercises on Breastfeeding Success and Breastfeeding Self-efficacy After Caesarean Section
- ClinicalTrials.gov ID
- NCT06070792
- Acronym / sponsor ID
- NLP, PMRE, AND BREASTFEEDING
- Keywords
- NEURO LINGUISTIC PROGRAM, PROGRESSIVE MUSCLE RELAXATION EXERCISES, CAESAREAN SECTION, BREASTFEEDING SUCCESS, BREASTFEEDING SELF-EFFICACY
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Aysegul KilicliUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 18 Dec 2023 (actual)
- Study completion
- 18 Dec 2023 (actual)
- First posted
- 6 Oct 2023 (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 neuro linguistic program and progressive muscle relaxation exercises on breastfeeding success and breastfeeding self-efficacy after caesarean section.
Detailed description
In this research, it is aimed to detemine the effect of neuro linguistic program and progressive muscle relaxation exercises on breastfeeding success and breastfeeding self-efficacy after caesarean section.
Sample size:
- There will be three groups in the study (two experimental groups and one control group).
- The sample size of the study is 99 people. The sample size will be divided into three and 33 people will be randomly assigned to each group.
- Experiment 1 group: neuro linguistic programme (NLP) group.
- Experiment 2 group: progressive muscle relaxation exercises (PMRE) group.
- Control group: non-intervention group
Data Collection Tools;
- Introductory Information Form,
- Breastfeeding Self-Efficacy Scale,
- Breastfeeding Charting System (LATCH)
Application time:
- NLP and PMRE interventions will be started at the sixth postoperative hour after caesarean section.
- Mothers who give birth by caesarean section are followed up in hospital for 48 hours and mothers are then discharged when their health condition improves. Therefore, data will be collected within 48 hours after caesarean section.
- NLP and PMRE groups will be started at the sixth postoperative hour, 3 times in 24 hours on the first day, 3 times in 24 hours on the second day, six times in total.
- Only NLP and PMRE will not be applied to the control group.
- Care and follow-up will be performed in parallel with the individuals in the experimental group.
Measurement time:
- Mothers will fill in the Introductory Information Form, Breastfeeding Self-Efficacy Scale, Breastfeeding Diagnosis and Assessment Measurement Tool (LATCH) before the application at the sixth postoperative hour.
- Then, in the first 24 hours, the necessary application will be performed once every eight hours according to the groups (for example, NLP application for experiment 1).
- At the end of 24th hour, Breastfeeding Self-Efficacy Scale and Breastfeeding Diagnosis and Assessment Measurement Tool (LATCH) will be completed.
- Then, in the second 24 hours, the interventions will be repeated once every eight hours.
- The total number of application sessions is six.
- NLP application will last 20 minutes each session and PMRE application will last 20 minutes each session.
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 |
|---|---|---|
| NEURO LINGUISTIC PROGRAM | Experimental | Other: NEURO LINGUISTIC PROGRAMfirst experimental group. It will be administered to primiparous mothers after caesarean section in the first 48 hours after the sixth postoperative hour, once every eight hours, for a total of six times. Each session will last 20 minutes. In the NLP application; firstly, the most frequently used visual, auditory and/or tactile representation system of the woman will be determined. Then, the internal and external reactions caused by the symptoms after caesarean section, her feelings and thoughts about her baby and breastfeeding will be combined with the anchoring technique. Then, with the swish technique, the existing negative emotions will be reduced and tried to be deleted from the most frequently used representation system. The woman's negative thoughts about breastfeeding will be changed in a positive direction with the belief change model. |
| PROGRESSIVE MUSCLE RELAXATION EXERCISES | Experimental | Other: PROGRESSIVE MUSCLE RELAXATION EXERCISESsecond experimental group. It will be administered to primiparous mothers after caesarean section in the first 48 hours after the sixth postoperative hour, once every eight hours, for a total of six times. Each session will last 20 minutes. PMRE; All muscles of the body will be tried to be relaxed respectively with the commands given gradually. |
| control | No intervention | –The control group will not receive NLP or PMRE. |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- women who gave birth by caesarean section,
- primiparous,
- who are 19 years of age or older and 35 years of age or younger,
- who were born at 37 or more weeks of gestation,
- who had a singleton birth,
Key exclusion criteria (3 listed)
- mothers who did not meet the inclusion criteria,
- who wanted to leave the study voluntarily at any stage after being included in the study,
- who developed any health problems in themselves or their infants were excluded.
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 |
|---|---|---|
| NEURO LINGUISTIC PROGRAMNEURO LINGUISTIC PROGRAM | Other | NEURO LINGUISTIC PROGRAM |
| PROGRESSIVE MUSCLE RELAXATION EXERCISESPROGRESSIVE MUSCLE RELAXATION EXERCISES | Other | PROGRESSIVE MUSCLE RELAXATION EXERCISES |
Primary outcome
BREASTFEEDING SUCCESS
Time frame: immediately before the first application
Breastfeeding Charting System (LATCH); The measurement tool has no cut-off point, and as the LATCH score increases, it is understood that the process is high. The maximum score that can be obtained is 10. The sum of lower scores indicates that the mother is dependent on help.
BREASTFEEDING SUCCESS
Time frame: immediately after the third application (at the 24th hour after the first application)
Breastfeeding Charting System (LATCH)
BREASTFEEDING SUCCESS
Time frame: immediately after the sixth application (at the 48th hour after the first application)
Breastfeeding Charting System (LATCH)
BREASTFEEDING SELF-EFFICACY
Time frame: immediately before the first application
Breastfeeding Self-Efficacy Scale; A minimum of 14 points and a maximum of 70 points can be obtained from the scale. All are positive elements. The higher the score from the scale, the higher breastfeeding self-efficacy will be achieved.
BREASTFEEDING SELF-EFFICACY
Time frame: immediately after the third application (at the 24th hour after the first application)
Breastfeeding Self-Efficacy Scale
BREASTFEEDING SELF-EFFICACY
Time frame: immediately after the sixth application (at the 48th hour after the first application)
Breastfeeding Self-Efficacy Scale
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 19 Sep 2024.
- Derived from this study: PubMed 39003935Kilicli A, Gul S. The effect of neurolinguistic programming and progressive muscle relaxation exercises on breastfeeding success and breastfeeding self-efficacy: A randomized controlled trial. Explore (NY). 2024 Sep-Oct;20(5):103027. doi: 10.1016/j.explore.2024.103027. Epub 2024 Jul 2.
- Individual participant dataSharing planned: No
Related trials for NEUROLINGUISTIC PROGRAMMING
Not yet recruiting
Two Sessions of Coach-Delivered Core Transformation for Distress and Well-Being
Psychological Distress, Psychological Well-being
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 NEURO LINGUISTIC PROGRAM and PROGRESSIVE MUSCLE RELAXATION EXERCISES in people with NEUROLINGUISTIC PROGRAMMING and PROGRESSIVE MUSCLE RELAXATION EXERCISES, 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 7 inclusion and 3 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 19 Sep 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?
BREASTFEEDING SUCCESS (time frame: immediately before the first application). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06070792, which also lists 1 linked publication.
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 Sep 2024.