Nursing CariesNCT05033405
Neuro Linguistic Programming Pain Levels After Cesarean Delivery
A study testing NEURO-LINGUISTIC PROGRAMMING (NLP) in people with Nursing Caries and Pain, Postoperative, run by Munzur University at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted to determine the effect of Neuro-Linguistic Programming (NLP) application on post-cesarean section pain levels. Read more about this study
- Who is it for?
- Ages 19 to 42 years, women only
- Conditions the study is for
- Nursing Caries, Pain, Postoperative
- What is being tested?
- NEURO-LINGUISTIC PROGRAMMING (NLP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2021to 21 Jun 2021
- 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 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- The study included individuals who
- had a cesarean section,
- were at the 6th to 24th hour postpartum,
- agreed to participate in the study,
- had a cesarean section for the first time,
- did not use patient-controlled analgesia (PCA),
- did not have an additional health problem that may cause pain in the postpartum period, other than cesarean incision pain, and
- could speak and understand Turkish.
Who cannot join
- Mothers who wanted to quit on their own will at any stage after being included in the study, had verbal communication problems, had hearing or vision problems, or had previously been diagnosed with a psychiatric illness were excluded from the sample.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Neuro Linguistic Programming on Pain Levels After Cesarean Delivery: A Randomized Controlled Trial
This study was conducted to determine the effect of Neuro-Linguistic Programming (NLP) application on post-cesarean section pain levels.
Read the detailed description
The study was carried out between March 1 and June 1, 2021 with mothers who gave birth through cesarean section in the postpartum service of a maternity and children's hospital in the most populated city of Turkey, which is located in the west. The study data consists of a total of 76 individuals, including 38 in the experimental group and 38 in the control group. In the study, the effect size was calculated as 2.22. Accordingly, the power of the study, which was completed with 38 individuals in the control group and 38 in experimental group, had an effect size of 2.22, and used a significance level of 0.05, was calculated as 99.9%. The power analysis was conducted on the G*Power software package.
- Conditions
- Nursing Caries, Pain, Postoperative
- Being tested
- NEURO-LINGUISTIC PROGRAMMING (NLP)
- Keywords
- NLP, cesarean section, postpartum, pain
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEURO-LINGUISTIC PROGRAMMING (NLP)Behavioural
● One session (20-minute long) of NLP application was performed. The NLP techniques that were employed were representational systems and submodality. In this technique, the sensory, auditory, and kinesthetic feelings of the individual are learned. These emotions are modified by imagining. The NLP application was carried out by a researcher who has a certificate in this field
| Study group | Role | What they receive |
|---|---|---|
| Experimental:Neuro Linguistic Programming | Experimental | One session (20-minute long) of NLP application was performed. The NLP techniques that were employed were representational systems and submodality. In this technique, the sensory, auditory, and kinesthetic feelings of the individual are learned. These emotions are modified by imagining. The NLP application was carried out by a researcher who has a certificate in this field. Receives: Behavioral: NEURO-LINGUISTIC PROGRAMMING (NLP) |
| control group | No intervention | No NLP was applied on the control group patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Examination of inter-and intra-group differences regarding VAS Scores
A mean total score on the Visual Analogue Scale (VAS). In this assessment, users score their pain from 0 to 10. The scores are interpreted as follows: "0", no pain at all; 1-4, mild pain; 5-6, moderate pain; and 7-10, severe pain.
A mean total score on the VAS of four and above indicates postoperative pain.
Measured: Immediately after the completion of the NLP application
Secondary outcomes (1)
Distribution of participant characteristics by groups
The effect of NLP application on post-operative pain in women who gave birth by cesarean section is examined. Comparisons are made by using Visual Analog Scale (VAS) mean scores in the experimental and control groups.
Measured: 20 minutes after the first administration of the VAS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start1 Mar 2021
- Primary completion1 Jun 2021
- Study completion21 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nursing CariesStudies 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
- Model description
- The study was conducted by using a prospective randomized single-blind clinical trial model.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Munzur University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nursel Alp Dal, Munzur University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05033405
- Sponsor's protocol ID
- 047213793060212
- Status last verified
- Aug 2021
- First submitted
- 18 Aug 2021
- Last updated
- 2 Sep 2021
- 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 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Neuro Linguistic Programming on Pain Levels After Cesarean Delivery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05033405
- Acronym / sponsor ID
- 047213793060212
- Conditions
- Nursing Caries, Pain, Postoperative
- Keywords
- NLP, cesarean section, postpartum, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Munzur UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 21 Jun 2021 (actual)
- First posted
- 2 Sep 2021 (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 effect of Neuro-Linguistic Programming (NLP) application on post-cesarean section pain levels.
Detailed description
The study was carried out between March 1 and June 1, 2021 with mothers who gave birth through cesarean section in the postpartum service of a maternity and children's hospital in the most populated city of Turkey, which is located in the west. The study data consists of a total of 76 individuals, including 38 in the experimental group and 38 in the control group. In the study, the effect size was calculated as 2.22. Accordingly, the power of the study, which was completed with 38 individuals in the control group and 38 in experimental group, had an effect size of 2.22, and used a significance level of 0.05, was calculated as 99.9%. The power analysis was conducted on the G*Power software package.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- The study was conducted by using a prospective randomized single-blind clinical trial model.
| Arm | Type | Receives |
|---|---|---|
| Experimental:Neuro Linguistic Programming | Experimental | Behavioral: NEURO-LINGUISTIC PROGRAMMING (NLP)One session (20-minute long) of NLP application was performed. The NLP techniques that were employed were representational systems and submodality. In this technique, the sensory, auditory, and kinesthetic feelings of the individual are learned. These emotions are modified by imagining. The NLP application was carried out by a researcher who has a certificate in this field. |
| control group | No intervention | –No NLP was applied on the control group patients. |
Who may qualify
- Ages
- 19 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- The study included individuals who
Key exclusion criteria (1 listed)
- Mothers who wanted to quit on their own will at any stage after being included in the study, had verbal communication problems, had hearing or vision problems, or had previously been diagnosed with a psychiatric illness were excluded from the sample.
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 PROGRAMMING (NLP)● One session (20-minute long) of NLP application was performed. The NLP techniques that were employed were representational systems and submodality. In this technique, the sensory, auditory, and kinesthetic feelings of the individual are learned. These emotions are modified by imagining. The NLP application was carried out by a researcher who has a certificate in this field | Behavioural | Experimental:Neuro Linguistic Programming |
Primary outcome
Examination of inter-and intra-group differences regarding VAS Scores
Time frame: Immediately after the completion of the NLP application
A mean total score on the Visual Analogue Scale (VAS). In this assessment, users score their pain from 0 to 10. The scores are interpreted as follows: "0", no pain at all; 1-4, mild pain; 5-6, moderate pain; and 7-10, severe pain. A mean total score on the VAS of four and above indicates postoperative pain.
1 secondary outcome
Distribution of participant characteristics by groups
Time frame: 20 minutes after the first administration of the VAS
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 2 Sep 2021.
- 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.
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 PROGRAMMING (NLP) in people with Nursing Caries and Pain, Postoperative, run by Munzur 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 8 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: finished, as of the sponsor's last update on 2 Sep 2021. 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?
Examination of inter-and intra-group differences regarding VAS Scores (time frame: Immediately after the completion of the NLP application). 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 2 Sep 2021.