First PregnancyNCT06435988
The Effect of Training With Pecha Kucha on Anxiety and Birth Satisfaction in Pregnant Women.
A study testing Training in the pecha kucha technique in people with First Pregnancy, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
For this purpose, the distribution of Pecha Kucha user's birth information education on state/trait anxiety and birth hope in primiparous pregnant women is determined. The main question the researcher aims to answer is: Do anxiety and birth changes in pregnant women who receive Pecha Kucha's registered birth… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- First Pregnancy
- What is being tested?
- Training in the pecha kucha technique
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2023to 30 Jun 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Primary pregnant women,
- Pregnant women aged 18 and over,
- Pregnant women in the latent phase of labor
- Pregnant women who do not have perinatological risk,
- Pregnant women who can understand and speak Turkish
Who cannot join
- • Risky pregnant women,
- Pregnant woman in active phase,
- Pregnant women who develop an obstetric complication during labor follow-up (Fetal distress, Cord prolapse, Uterine hyperstimulation, non-progressive labor, malpresentation, etc.).
- There is a problem that prevents communication
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kocaeli Üniversitesi
Gebze, Kocaeli̇, 41400
resmiye özdilek, doç, 0 262 303 47 38, resmiyeozdilek@gmail.com
hatice gamze reçber
About this study
Official title: The Effect of the Training Given Using the Pecha Kucha Technique on the Anxiety and Birth Satisfaction of the First Pregnant Women Followed in Labor.
For this purpose, the distribution of Pecha Kucha user's birth information education on state/trait anxiety and birth hope in primiparous pregnant women is determined.
The main question the researcher aims to answer is:
Do anxiety and birth changes in pregnant women who receive Pecha Kucha's registered birth information training? There are 25 pregnant women in the experimental and 25 control groups. After the training, participants in the experimental groups will answer the satisfaction survey and questions about trait anxiety.
Read the detailed description
The research was started after receiving ethics committee approval and written approval from the relevant institution. Pechka kucha presentation was prepared by the researcher in accordance with the literature information and the features required by the technique. For the content validity of the travay information presentation prepared with the PK technique, expert opinions were received from 10 academicians who have scientific studies on this subject.
After receiving expert approval of the presentation, the data collection process began. The research population consists of primiparous pregnant women who were admitted to the delivery room and followed during birth. The participants included in the study were assigned to groups through randomization, ensuring homogeneity in the distribution of the groups. "Random Allocation Software Program" was used to randomize the participants into groups, and the randomization list of the study was created by determining the number of each participant and the number of groups.
Participants admitted to the delivery room for normal birth, in the order on the randomization list; were assigned as a control and an experimental group by the researcher.
Only participants assigned to the randomization group were studied until completion. After the birth of the participants was completed, the first participant who was admitted to the delivery room and met the research criteria was assigned to the other group on the randomization list and the necessary interventions were carried out. If the participant has a cesarean section during the study or leaves the study for any reason; The first participant admitted to the delivery room and meeting the research criteria will be assigned to the other group on the randomization list.
The research was explained to the participant assigned to the experimental group, and if voluntary participation was required, the 'Informed Consent Form' was signed.
Participants in the experimental group were given 'Pecha Kucha Travay Information' training. The presentation was held in the TDL (Labor-Delivery-Postpartum) unit, in single rooms, with a seating arrangement facing each other. The presentation was made on the researcher's tablet with an 8-inch screen size. The position of the tablet was adjusted to the middle point in the seating arrangement of the participant and the researcher. Before the training, he was informed about the duration of the presentation and it was stated that he could talk about the questions he wanted to ask at the end of the presentation.
The presentation, prepared with the Pechka Kucha method and lasting 6 minutes and 20 seconds, was explained to the participant via tablet. Then, the introductory information form and the state-trait anxiety scale were filled out. After birth, participants in the experimental group filled out the 'Birth Satisfaction Scale' before being transferred from the delivery room to the ward.
- Conditions
- First Pregnancy
- Being tested
- Training in the pecha kucha technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training in the pecha kucha techniqueBehavioural
Providing labor training to pregnant women with the Pecha Kucha technique
| Study group | Role | What they receive |
|---|---|---|
| no ıntervention | No intervention | no ıntervention |
| experimental | Experimental | Training in the pecha kucha technique Receives: Behavioral: Training in the pecha kucha technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
State and Trait Anxiety ScaleWomen.
After the total weights of the direct and reversed expressions are found separately, the total weight score of the reverse expressions is subtracted from the total weight score obtained for the direct expressions. A predetermined and unchanging value is added to this number. This constant value is 50 for the State Anxiety Scale and 35 for the Trait Anxiety Scale. The final value obtained represents the individual's anxiety score.
Measured: 24 hours
Birth Experience Scale
The scale, which was developed to measure women's birth experience in different dimensions, has four sub-dimensions and 22 items. The first 19 items of the scale are evaluated using a four-point scale and the last three items are evaluated using VAS. In DSS, the first 19 items are scored from 1 to 4; I completely agree = 1, I mostly agree = 2, I partially agree = 3, I completely disagree = 4.
The scores on the VAS scale are categorical; It is classified as 0-40 = 1, 41-60 = 2, 61-80 = 3, 81-100 = 4. Cronbach's alpha value of the scale; 0.56 for the Birth Process sub-dimension, 0.73 for the Professional Support/Help subscale, 0.63 for the Perceived Security/Memories subscale, 0.64 for Participation in Decisions sub-dimension The total scale Cronbach alpha reliability coefficient was found to be 0.76.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start15 Jul 2023
- Primary completion30 May 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for First PregnancyStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice Gamze Recber, Kocaeli University
- Investigators
- resmiye özdilek, Asst.Prof., Study director, Kocaeli University Faculty of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06435988
- Sponsor's protocol ID
- HGRecber
- Status last verified
- May 2024
- First submitted
- 14 May 2024
- Last updated
- 30 May 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 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Training Given Using the Pecha Kucha Technique on the Anxiety and Birth Satisfaction of the First Pregnant Women Followed in Labor.
- ClinicalTrials.gov ID
- NCT06435988
- Acronym / sponsor ID
- HGRecber
- Conditions
- First Pregnancy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 15 Jul 2023 (actual)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 30 May 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.
For this purpose, the distribution of Pecha Kucha user's birth information education on state/trait anxiety and birth hope in primiparous pregnant women is determined.
The main question the researcher aims to answer is:
Do anxiety and birth changes in pregnant women who receive Pecha Kucha's registered birth information training? There are 25 pregnant women in the experimental and 25 control groups. After the training, participants in the experimental groups will answer the satisfaction survey and questions about trait anxiety.
Detailed description
The research was started after receiving ethics committee approval and written approval from the relevant institution. Pechka kucha presentation was prepared by the researcher in accordance with the literature information and the features required by the technique. For the content validity of the travay information presentation prepared with the PK technique, expert opinions were received from 10 academicians who have scientific studies on this subject.
After receiving expert approval of the presentation, the data collection process began. The research population consists of primiparous pregnant women who were admitted to the delivery room and followed during birth. The participants included in the study were assigned to groups through randomization, ensuring homogeneity in the distribution of the groups. "Random Allocation Software Program" was used to randomize the participants into groups, and the randomization list of the study was created by determining the number of each participant and the number of groups.
Participants admitted to the delivery room for normal birth, in the order on the randomization list; were assigned as a control and an experimental group by the researcher.
Only participants assigned to the randomization group were studied until completion. After the birth of the participants was completed, the first participant who was admitted to the delivery room and met the research criteria was assigned to the other group on the randomization list and the necessary interventions were carried out. If the participant has a cesarean section during the study or leaves the study for any reason; The first participant admitted to the delivery room and meeting the research criteria will be assigned to the other group on the randomization list.
The research was explained to the participant assigned to the experimental group, and if voluntary participation was required, the 'Informed Consent Form' was signed.
Participants in the experimental group were given 'Pecha Kucha Travay Information' training. The presentation was held in the TDL (Labor-Delivery-Postpartum) unit, in single rooms, with a seating arrangement facing each other. The presentation was made on the researcher's tablet with an 8-inch screen size. The position of the tablet was adjusted to the middle point in the seating arrangement of the participant and the researcher. Before the training, he was informed about the duration of the presentation and it was stated that he could talk about the questions he wanted to ask at the end of the presentation.
The presentation, prepared with the Pechka Kucha method and lasting 6 minutes and 20 seconds, was explained to the participant via tablet. Then, the introductory information form and the state-trait anxiety scale were filled out. After birth, participants in the experimental group filled out the 'Birth Satisfaction Scale' before being transferred from the delivery room to the ward.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| no ıntervention | No intervention | –no ıntervention |
| experimental | Experimental | Behavioral: Training in the pecha kucha techniqueTraining in the pecha kucha technique |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Primary pregnant women,
- Pregnant women aged 18 and over,
- Pregnant women in the latent phase of labor
- Pregnant women who do not have perinatological risk,
- Pregnant women who can understand and speak Turkish
Key exclusion criteria (4 listed)
- • Risky pregnant women,
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 |
|---|---|---|
| Training in the pecha kucha techniqueProviding labor training to pregnant women with the Pecha Kucha technique | Behavioural | experimental |
Primary outcome
State and Trait Anxiety ScaleWomen.
Time frame: 24 hours
After the total weights of the direct and reversed expressions are found separately, the total weight score of the reverse expressions is subtracted from the total weight score obtained for the direct expressions. A predetermined and unchanging value is added to this number. This constant value is 50 for the State Anxiety Scale and 35 for the Trait Anxiety Scale. The final value obtained represents the individual's anxiety score.
Birth Experience Scale
Time frame: 24 hours
The scale, which was developed to measure women's birth experience in different dimensions, has four sub-dimensions and 22 items. The first 19 items of the scale are evaluated using a four-point scale and the last three items are evaluated using VAS. In DSS, the first 19 items are scored from 1 to 4; I completely agree = 1, I mostly agree = 2, I partially agree = 3, I completely disagree = 4. The scores on the VAS scale are categorical; It is classified as 0-40 = 1, 41-60 = 2, 61-80 = 3, 81-100 = 4. Cronbach's alpha value of the scale; 0.56 for the Birth Process sub-dimension, 0.73 for the Professional Support/Help subscale, 0.63 for the Perceived Security/Memories subscale, 0.64 for Participation in Decisions sub-dimension The total scale Cronbach alpha reliability coefficient was found to be 0.76.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- Individual participant dataSharing planned: No
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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.
resmiye özdilek, Asst.Prof. study director
Kocaeli University Faculty of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training in the pecha kucha technique in people with First Pregnancy, run by Kocaeli 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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 30 May 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gamze Reçber (905330921269, gamzerecber147@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State and Trait Anxiety ScaleWomen. (time frame: 24 hours). The study lists 2 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 30 May 2024.