Kidney Transplant PatientsNCT05115435
The Effect of Neuro Linguistic Programming on COVID-19 Fear in Kidney Transplant
A study testing neuro linguistic programming in people with Kidney Transplant Patients, run by Inonu University at 2 sites in Turkey (Türkiye).
Trial summary
The study was conducted experimentally to evaluate the effect of neurolinguistic programming on COVID-19 fear in kidney transplant patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant Patients
- What is being tested?
- neuro linguistic programming
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Mar 2021to 1 Nov 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria:Patients who could communicate verbally, had no hearing problems, had a high or moderate fear of Covid-19 (20 or more), and had not applied NLP before were included in the study.
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Exclusion Criteria: Patients who wanted to leave voluntarily at any stage after being included in the study, and who had to be hospitalized again for organ rejection or any other reason while the study was ongoing, were excluded from the study.
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Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
İnönü University
Malatya, 44100
İnönü Üniversitesi
Malatya, 44100
About this study
The study was conducted experimentally to evaluate the effect of neurolinguistic programming on COVID-19 fear in kidney transplant patients.
Read the detailed description
The study was conducted experimentally (prospective randomized single-blind clinical trial model) to evaluate the effect of neurolinguistic programming (NLP) on fear of Covid-19 in kidney transplant patients.
The study was carried out between June 2021 and October 2021. Personal Information Form and Fear of COVID-19 Scale (FCV-19S) were used to collect data. The data obtained from the research were evaluated with SPSS 25.
According to the calculation made using G*power 3.1 software, the sample size was determined as 74 (each group 37) with an effect size of 0.80, a margin of error of 0co.05, a confidence level of 0.95, and a population representation of 0.95. Simple random sampling method, one of the probability sampling methods, was used to determine the participants. Single-group columns between 1 and 300 were created using the Random Integer Generator method, which located in the Numbers sub-heading of the random.org website for the participants who met the sample selection criteria. Participants were randomly assigned to numbers 1 and 2, considering the numbers 1 and 2 in the column. The number of the experimental or control group was determined by drawing lots at the beginning of the research
- Conditions
- Kidney Transplant Patients
- Being tested
- neuro linguistic programming
- Keywords
- Neuro Linguistic Programming, fear of covid-19, kidney transplant patients, nurse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neuro linguistic programmingBehavioural
Sub modality Technique: People experience the world with their five senses, and the thoughts that an individual creates in his brain about a situation are coded with these five senses. When these encodings change, the individual's perception of the situation will also change
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | No intervention was applied on the control group patients |
| experimental group | Experimental | Sub modality Technique: People experience the world with their five senses, and the thoughts that an individual creates in his brain about a situation are coded with these five senses. When these encodings change, the individual's perception of the situation will also change Receives: Behavioral: neuro linguistic programming |
What is being measured
The primary outcome is the main question the study is designed to answer.
A mean total score on the
Fear of COVID-19 Scale (FCV-19S)
Measured: Fear of COVID-19 Scale . After applying the personal information form and Fear of COVID-19 Scale (FCV-19S) to the patients in the experimental group, the sub-modality technique of NLP was applied once, and then FCV-19S was applied again one week later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2021
- Study start1 Mar 2021
- Primary completion1 Aug 2021
- Study completion1 Nov 2021
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 Kidney Transplant PatientsStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- 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 population of the study consisted of patients who had kidney transplants in the hospital in question. The sample of the study was determined by power analysis. According to the calculation made using G\*power 3.1 software, the sample size was determined as 74 (each group 37) with an effect size of 0.80, a margin of error of 0co.05, a confidence level of 0.95, and a population representation of 0.95. Simple random sampling method, one of the probability sampling methods, was used to determine the participants. Single-group columns between 1 and 300 were created using the Random Integer Generator method, which located in the Numbers sub-heading of the random.org website for the participants who met the sample selection criteria. Participants were randomly assigned to numbers 1 and 2, considering the numbers 1 and 2 in the column. The number of the experimental or control group was determined by drawing lots at the beginning of the research.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Runida Dogan, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05115435
- Sponsor's protocol ID
- RDNLP
- Status last verified
- Nov 2021
- First submitted
- 8 Nov 2021
- Last updated
- 10 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data can be shared with the permission of the researchers.
Publications
Dogan A, Dogan R, Menekli T, Berktas HB. Effect of neuro-linguistic programming on COVID-19 fear in kidney transplant patients: A randomized controlled study. Complement Ther Clin Pract. 2022 Nov;49:101638. doi: 10.1016/j.ctcp.2022.101638. Epub 2022 Jul 4.
PubMed 35843115
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Neuro Linguistic Programming on COVID-19 Fear in Kidney Transplant
- ClinicalTrials.gov ID
- NCT05115435
- Acronym / sponsor ID
- RDNLP
- Conditions
- Kidney Transplant Patients
- Keywords
- Neuro Linguistic Programming, fear of covid-19, kidney transplant patients, nurse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 10 Nov 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.
The study was conducted experimentally to evaluate the effect of neurolinguistic programming on COVID-19 fear in kidney transplant patients.
Detailed description
The study was conducted experimentally (prospective randomized single-blind clinical trial model) to evaluate the effect of neurolinguistic programming (NLP) on fear of Covid-19 in kidney transplant patients.
The study was carried out between June 2021 and October 2021. Personal Information Form and Fear of COVID-19 Scale (FCV-19S) were used to collect data. The data obtained from the research were evaluated with SPSS 25.
According to the calculation made using G*power 3.1 software, the sample size was determined as 74 (each group 37) with an effect size of 0.80, a margin of error of 0co.05, a confidence level of 0.95, and a population representation of 0.95. Simple random sampling method, one of the probability sampling methods, was used to determine the participants. Single-group columns between 1 and 300 were created using the Random Integer Generator method, which located in the Numbers sub-heading of the random.org website for the participants who met the sample selection criteria. Participants were randomly assigned to numbers 1 and 2, considering the numbers 1 and 2 in the column. The number of the experimental or control group was determined by drawing lots at the beginning of the research
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The population of the study consisted of patients who had kidney transplants in the hospital in question. The sample of the study was determined by power analysis. According to the calculation made using G*power 3.1 software, the sample size was determined as 74 (each group 37) with an effect size of 0.80, a margin of error of 0co.05, a confidence level of 0.95, and a population representation of 0.95. Simple random sampling method, one of the probability sampling methods, was used to determine the participants. Single-group columns between 1 and 300 were created using the Random Integer Generator method, which located in the Numbers sub-heading of the random.org website for the participants who met the sample selection criteria. Participants were randomly assigned to numbers 1 and 2, considering the numbers 1 and 2 in the column. The number of the experimental or control group was determined by drawing lots at the beginning of the research.
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –No intervention was applied on the control group patients |
| experimental group | Experimental | Behavioral: neuro linguistic programmingSub modality Technique: People experience the world with their five senses, and the thoughts that an individual creates in his brain about a situation are coded with these five senses. When these encodings change, the individual's perception of the situation will also change |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 programmingSub modality Technique: People experience the world with their five senses, and the thoughts that an individual creates in his brain about a situation are coded with these five senses. When these encodings change, the individual's perception of the situation will also change | Behavioural | experimental group |
Primary outcome
A mean total score on the
Time frame: Fear of COVID-19 Scale . After applying the personal information form and Fear of COVID-19 Scale (FCV-19S) to the patients in the experimental group, the sub-modality technique of NLP was applied once, and then FCV-19S was applied again one week later
Fear of COVID-19 Scale (FCV-19S)
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 10 Nov 2021.
- Derived from this study: PubMed 35843115Dogan A, Dogan R, Menekli T, Berktas HB. Effect of neuro-linguistic programming on COVID-19 fear in kidney transplant patients: A randomized controlled study. Complement Ther Clin Pract. 2022 Nov;49:101638. doi: 10.1016/j.ctcp.2022.101638. Epub 2022 Jul 4.
- Individual participant dataSharing planned: Undecided. Data can be shared with the permission of the researchers.
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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.
2 sites 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 in people with Kidney Transplant Patients, run by Inonu University at 2 sites 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?
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 10 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
A mean total score on the (time frame: Fear of COVID-19 Scale . After applying the personal information form and Fear of COVID-19 Scale (FCV-19S) to the patients in the experimental group, the sub-modality technique of NLP was applied once, and then FCV-19S was applied again one week later). 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 NCT05115435, 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 10 Nov 2021.