Humor as TopicNCT06299397
Breastfeeding Education and Humor-Based Practices on Breastfeeding
A study testing breastfeeding - humor training in people with Humor as Topic and Breast Feeding, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to determine the effect of breastfeeding education and humor-based practices in the antenatal period on breastfeeding motivation and attachment. 32-36 patients who applied to Bartın Gynecology and Children's Hospital for the project. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Humor as Topic, Breast Feeding, Mother-Child Relations
- What is being tested?
- breastfeeding - humor training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Jun 2023to 14 Feb 2024
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being over 18 years of age,
- Having a healthy pregnancy,
- Being literate,
- 32-36. Being in the gestational week,
- Being primiparous,
- Not having any psychiatric diagnosis.
Who cannot join
- Not having attended one of the trainings
- incompletely filling out the questionnaires
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Breastfeeding Education and Humor-Based Practices on Breastfeeding Motivation and Attachment in the Antenatal Period
The aim of this study is to determine the effect of breastfeeding education and humor-based practices in the antenatal period on breastfeeding motivation and attachment. 32-36 patients who applied to Bartın Gynecology and Children's Hospital for the project. It will consist of 64 pregnant women (32 experimental and 32 control group) at gestational week. Pregnant women who agree to participate in the project between these months will receive 30-45 minutes of humor practice after 30 minutes of breastfeeding training in the first session. The education and humor application will be implemented again a week later, on the same day, at the same time and in the same place. In the humor application, dance performances, applause, singing and laughter accompanied by 5 songs determined by the researchers will be included. The training program prepared for breastfeeding education will be applied to pregnant women. Then, humor will be applied. A pre-test will be administered before the training, a mid-test 1 month after the training, and a post-test in the 3rd month. Project data will be collected using the 'Introductory Information Form', 'Breastfeeding Motivation Scale' and 'Maternal Attachment Scale'.
Read the detailed description
Breastfeeding is the ideal source of nutrition for babies. The World Health Organization (WHO) recommends continuing breastfeeding exclusively with breast milk for the first 6 months and with complementary foods for up to 3 years. Breastfeeding is extremely effective on the health of the baby and mother. The aim of this study is to determine the effect of breastfeeding education and humor-based practices in the antenatal period on breastfeeding motivation and attachment. 32-36 patients who applied to Bartın Gynecology and Children's Hospital for the project. It will consist of 64 pregnant women (32 experimental and 32 control group) at gestational week. Pregnant women who agree to participate in the project between these months will receive 30-45 minutes of humor practice after 30 minutes of breastfeeding training in the first session. The education and humor application will be implemented again a week later, on the same day, at the same time and in the same place. In the humor application, dance performances, applause, singing and laughter accompanied by 5 songs determined by the researchers will be included. The training program prepared for breastfeeding education will be applied to pregnant women. Then, humor will be applied. A pre-test will be administered before the training, a mid-test 1 month after the training, and a post-test in the 3rd month. Project data will be collected using the 'Introductory Information Form', 'Breastfeeding Motivation Scale' and 'Maternal Attachment Scale'.
- Being tested
- breastfeeding - humor training, Control Group
- Keywords
- humor as topic, breastfeeding, bonding, antenatal, motivation
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
breastfeeding - humor trainingBehavioural
Breastfeeding and humor-based practice will continue for 35-45 minutes, once a week for 2 weeks.
Control GroupOther
After randomization, consent was obtained from the pregnant women determined that they agreed to participate in the study. The pregnant women in the control group were given a pre-test before starting the study, an interim test 1 month after the start, and a final test 3 months later.
| Study group | Role | What they receive |
|---|---|---|
| Breastfeeding-Humor group | Experimental | 32 pregnant women were included in the experimental group determined by randomization method. Consent to participate in the study was obtained from these pregnant women. After obtaining consent, a pre-test was conducted. Afterwards, pregnant women were given breastfeeding education and humor practice. The application was applied once a week, twice a week. An interim test was administered 1 month after the application, and a final test was administered 3 months later. Receives: Behavioral: breastfeeding - humor training |
| Control Group | Sham comparator | After randomization, consent was obtained from the pregnant women determined that they agreed to participate in the study. The pregnant women in the control group were given a pre-test before starting the study, an interim test 1 month after the start, and a final test 3 months later. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breastfeeding Motivation Scale
The scale consists of 24 items and 5 sub-dimensions. Subdimensions of the scale; They were determined as intrinsic motivation, integrated regulation, identified regulation, introjected regulation, and external regulation. Scale items are rated between 'I strongly disagree' (1 point) and 'I strongly agree' (4 points). The scale is a 4-point Likert type, and each item receives a score between 1 and 4. The total score of the scale is not calculated. The score of the sub-dimensions is calculated by taking the average of the scale sub-dimension scores. It has been stated that the higher the score received from the scale sub-dimension, the higher the motivation representing that sub-dimension
Measured: 3 month
Secondary outcomes (1)
Maternal Attachment Scale
It is a 26-item 4-point Likert type scale, with each item ranging from "always" to "never". Each item contains direct statements and is calculated as Always (a) = 4 points, Often (b) = 3 points, Sometimes (c) = 2 points and Never (d) = 1 point. An overall score is obtained from the sum of all items. A high score indicates high maternal attachment. The lowest score obtained from the scale varies between 26 and the highest score 104. The scale has no cut-off score.
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start14 Jun 2023
- Primary completion14 Jul 2023
- Study completion14 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Humor as TopicStudies 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
- Parallel groups
- Model description
- Participants determined by the researchers before starting the study were divided into experimental and control groups by randomization method. Humor-based breastfeeding education was given to women in the experimental group for 35-45 minutes once a week for 2 weeks on specified days and hours. Breastfeeding education was given in practice. Then, humor was practiced with songs and clown costumes. An interim test was administered one month after this application and a final test was administered three months later.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simge Ozturk, Inonu University
- Investigators
- Simge Ozturk, Ph.D, Principal investigator, Bartın Unıversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06299397
- Sponsor's protocol ID
- Inonu-SBF-4
- Status last verified
- Mar 2024
- First submitted
- 1 Mar 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Breastfeeding Education and Humor-Based Practices on Breastfeeding Motivation and Attachment in the Antenatal Period
- ClinicalTrials.gov ID
- NCT06299397
- Acronym / sponsor ID
- Inonu-SBF-4
- Keywords
- humor as topic, breastfeeding, bonding, antenatal, motivation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 14 Jun 2023 (actual)
- Primary completion
- 14 Jul 2023 (actual)
- Study completion
- 14 Feb 2024 (actual)
- First posted
- 7 Mar 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 aim of this study is to determine the effect of breastfeeding education and humor-based practices in the antenatal period on breastfeeding motivation and attachment. 32-36 patients who applied to Bartın Gynecology and Children's Hospital for the project. It will consist of 64 pregnant women (32 experimental and 32 control group) at gestational week. Pregnant women who agree to participate in the project between these months will receive 30-45 minutes of humor practice after 30 minutes of breastfeeding training in the first session. The education and humor application will be implemented again a week later, on the same day, at the same time and in the same place. In the humor application, dance performances, applause, singing and laughter accompanied by 5 songs determined by the researchers will be included. The training program prepared for breastfeeding education will be applied to pregnant women. Then, humor will be applied. A pre-test will be administered before the training, a mid-test 1 month after the training, and a post-test in the 3rd month. Project data will be collected using the 'Introductory Information Form', 'Breastfeeding Motivation Scale' and 'Maternal Attachment Scale'.
Detailed description
Breastfeeding is the ideal source of nutrition for babies. The World Health Organization (WHO) recommends continuing breastfeeding exclusively with breast milk for the first 6 months and with complementary foods for up to 3 years. Breastfeeding is extremely effective on the health of the baby and mother. The aim of this study is to determine the effect of breastfeeding education and humor-based practices in the antenatal period on breastfeeding motivation and attachment. 32-36 patients who applied to Bartın Gynecology and Children's Hospital for the project. It will consist of 64 pregnant women (32 experimental and 32 control group) at gestational week. Pregnant women who agree to participate in the project between these months will receive 30-45 minutes of humor practice after 30 minutes of breastfeeding training in the first session. The education and humor application will be implemented again a week later, on the same day, at the same time and in the same place. In the humor application, dance performances, applause, singing and laughter accompanied by 5 songs determined by the researchers will be included. The training program prepared for breastfeeding education will be applied to pregnant women. Then, humor will be applied. A pre-test will be administered before the training, a mid-test 1 month after the training, and a post-test in the 3rd month. Project data will be collected using the 'Introductory Information Form', 'Breastfeeding Motivation Scale' and 'Maternal Attachment Scale'.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Participants determined by the researchers before starting the study were divided into experimental and control groups by randomization method. Humor-based breastfeeding education was given to women in the experimental group for 35-45 minutes once a week for 2 weeks on specified days and hours. Breastfeeding education was given in practice. Then, humor was practiced with songs and clown costumes. An interim test was administered one month after this application and a final test was administered three months later.
| Arm | Type | Receives |
|---|---|---|
| Breastfeeding-Humor group | Experimental | Behavioral: breastfeeding - humor training32 pregnant women were included in the experimental group determined by randomization method. Consent to participate in the study was obtained from these pregnant women. After obtaining consent, a pre-test was conducted. Afterwards, pregnant women were given breastfeeding education and humor practice. The application was applied once a week, twice a week. An interim test was administered 1 month after the application, and a final test was administered 3 months later. |
| Control Group | Sham comparator | Other: Control GroupAfter randomization, consent was obtained from the pregnant women determined that they agreed to participate in the study. The pregnant women in the control group were given a pre-test before starting the study, an interim test 1 month after the start, and a final test 3 months later. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Being over 18 years of age,
- Having a healthy pregnancy,
- Being literate,
- 32-36. Being in the gestational week,
- Being primiparous,
Key exclusion criteria (2 listed)
- Not having attended one of the trainings
- incompletely filling out the questionnaires
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 |
|---|---|---|
| breastfeeding - humor trainingBreastfeeding and humor-based practice will continue for 35-45 minutes, once a week for 2 weeks. | Behavioural | Breastfeeding-Humor group |
| Control GroupAfter randomization, consent was obtained from the pregnant women determined that they agreed to participate in the study. The pregnant women in the control group were given a pre-test before starting the study, an interim test 1 month after the start, and a final test 3 months later. | Other | Control Group |
Primary outcome
Breastfeeding Motivation Scale
Time frame: 3 month
The scale consists of 24 items and 5 sub-dimensions. Subdimensions of the scale; They were determined as intrinsic motivation, integrated regulation, identified regulation, introjected regulation, and external regulation. Scale items are rated between 'I strongly disagree' (1 point) and 'I strongly agree' (4 points). The scale is a 4-point Likert type, and each item receives a score between 1 and 4. The total score of the scale is not calculated. The score of the sub-dimensions is calculated by taking the average of the scale sub-dimension scores. It has been stated that the higher the score received from the scale sub-dimension, the higher the motivation representing that sub-dimension
1 secondary outcome
Maternal Attachment Scale
Time frame: 3 month
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 12 Mar 2024.
- Individual participant dataSharing planned: No
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.
Simge Ozturk, Ph.D principal investigator
Bartın Unıversity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing breastfeeding - humor training in people with Humor as Topic and Breast Feeding, run by Inonu 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 6 inclusion and 2 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 12 Mar 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. Some participants in this study may receive a placebo. 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 Motivation Scale (time frame: 3 month). 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 12 Mar 2024.