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AnxietyNCT04696991

Effect of the Pecha-Kucha Method on the Discharge Readiness and Anxiety Levels

A study testing The postpartum discharge education with PechaKucha Method. in people with Anxiety and Post Procedural Discharge, run by Aysegul Durmaz at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

H1a: Between the women receiving discharge training with the PechaKucha method by using smartphones and the women taking the routine discharge training in the early postpartum period, there is a statistically significant difference in the discharge readiness levels. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
What is being tested?
The postpartum discharge education with PechaKucha Method.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
1 siteTurkey (Türkiye)
Study dates
4 Feb 2019to 31 Aug 2019
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

  • To receive postpartum discharge training with PechaKucha method
  • To have cesarean birth
  • To have singleton birth
  • To be within the early postpartum period (the first 48 hours)
  • Not have complications at childbirth
  • Not have chronic diseases or mental disorders
Show all 13Show fewer
  • Older than 18 years
  • To voluntary to participate
  • To know how to read, write and speak in Turkish
  • To stay within this study until the end
  • To fully complete questionnaire
  • To have a newborn with no complications
  • To have a healthy baby

Who cannot join

  • To receive routine postpartum discharge training
  • Not have cesarean birth
  • Having multiple birth
  • Not to be within the early postpartum period (the first 48 hours)
  • Having complications at childbirth
  • Having chronic diseases or mental disorders
Show all 13Show fewer
  • Younger than 18 years
  • To refuse to participate
  • Not knowing how to read, write and speak Turkish
  • To leave early this study
  • Not fill the questionnaire
  • Having a newborn with complications
  • Having a baby in need of medical care

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Kutahya Health Science University

    Kütahya, 43000

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Pecha-Kucha Method on the Discharge Readiness and Anxiety Levels: A Randomized Controlled Trial

H1a: Between the women receiving discharge training with the PechaKucha method by using smartphones and the women taking the routine discharge training in the early postpartum period, there is a statistically significant difference in the discharge readiness levels.

H1b: Between the women receiving discharge training with the PechaKucha method by using smartphones and the women taking the routine discharge training in the early postpartum period, there is a statistically significant difference in the anxiety levels.

Read more

H0a: Between the women receiving discharge training with the PechaKucha method by using smartphones and the women taking the routine discharge training in the early postpartum period, there is no statistically significant difference in the discharge readiness levels.

H0b: Between the women receiving discharge training with the PechaKucha method by using smartphones and the women taking the routine discharge training in the early postpartum period, there is no statistically significant difference in the anxiety levels.

Read the detailed description

The research was conducted as a single-blind controlled study with simple random sampling. It was carried out at a tertiary-level hospital in Turkey in February-August 2019.

The research population was composed of the mothers who had cesarean delivery at the maternity service of a tertiary-level hospital in Turkey. The size of the research sample was calculated with power analysis. Considering the likelihood that some participants would later be excluded from the research or leave it, a total of 156 mothers who met the inclusion criteria for the research were assigned to the experimental group (78) and control group (78).

Both the experimental and control groups each had 78 mothers, and hence, a total of 156 mothers were included in the study. The postpartum discharge training in which the PechaKucha method was applied via the smartphones was offered to the mothers in the experimental group whereas the mothers in the control group had solely the routine discharge training. The research was completed with the participation of 140 mothers, namely, 70 mothers in the experimental group and 70 mothers in the control group. The discharge training which was comprised of 20 slides created as per the PechaKucha method was offered to the mothers in the experimental group via smartphones. Each slide was displayed for 20 seconds. The presentation took 6 minutes 40 seconds in total. The Q\&A session was performed after the presentation. While care was provided and the follow-up activities were performed in the process following the discharge training, feedback about the discharge training topics was received from both groups, discharge training topics were reminded to both groups and the questions of the mothers in both groups were answered.

The 'Personal Information Form', the 'Readiness for Hospital Discharge Scale - New Mother Form', and the 'State-Trait Anxiety Inventory' were used for gathering the research data.

In the statistical analysis, the SPSS (Statistical Package for Social Science) 22.0 software was utilized. Descriptive statistics (mean, standard deviation, frequency, percentage) were used in the evaluation of the findings. Kolmogorov-Smirnov test was employed for identifying whether the research data were normally distributed.

Being tested
The postpartum discharge education with PechaKucha Method.
Keywords
PechaKucha, Postpartum Discharge, Anxiety, Mobile Phone
Medical subject headings
Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The postpartum discharge education with PechaKucha Method.Behavioural

    The postpartum discharge training in which the PechaKucha method was applied via the smartphones was offered to the mothers in the experimental group whereas the mothers in the control group had solely the routine discharge training. The postpartum training was offered as per the Postpartum Care Management Guideline of the Ministry of Health of Turkey. The discharge training was offered to the experimental group by using the PechaKucha presentation technique.

Study groups in NCT04696991
Study groupRoleWhat they receive
Experimental GroupExperimentalThe mothers in the experimental group (70) were given the postpartum discharge education with PechaKucha Method.
Receives: Behavioral: The postpartum discharge education with PechaKucha Method.
Control GroupNo interventionThe mothers in the control group (70) were given the routine postpartum discharge education.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pre-Test Readiness for Postpartum Discharge

    Perceived Readiness for Discharge After Birth Scale-Form for New Mothers (PRDABS-FNM); This is a scale assessing the readiness for discharge by mothers' perceptions. It consists of four subdimensions and 23 items. The first item is answered dichotomously (yes/no). The items between 2 and 23 are calculated through the Likert type points ranging from 0 to 10. The subdimensions consisted of 1. Care skills, 2. Expected support; 3. Strength and ability to cope; 4. Stress control and knowledge of accessing help. The lowest and highest scores are 0 and 220. High scores indicate women's readiness for discharge.

    Measured: the pretest was applied in the first 8-12 hours in the postpartum period.

  2. Pre-Test Anxiety Level

    State-Trait Anxiety Inventory (STAI): The scale which was developed in 1970 by Spielberger, Gorsuch, and Lushene is comprised of two parts for measuring state anxiety and trait anxiety. Each part has 20 items. The STAI-State is scored as per the severity level of the emotions and behaviors (1: Not at all, 2: Somewhat, 3: Moderately so, and 4: Very much so). In the STAI-State, there are ten reverse-scored items (Items 1, 2, 5, 8, 10, 11, 15, 16, 19, and 20). The items of the STAI-Trait are scored as per the expression frequency of the emotions and behaviors (1: Almost never, 2: Sometimes, 3: Often, and 4: Almost always). In the STAI-Trait, there are seven reverse-scored items (Items 21, 26, 27, 30, 33, 36, and 39). In the scoring, two separate keys are prepared for identifying the total weighted values of the straight-scored and reverse-scored items. These constant values are 50 and 35 respectively for the STAI-State and STAI-Trait.

    Measured: the pretest was applied in the first 8-12 hours in the postpartum period.

Secondary outcomes (2)
  1. Post-Test Readiness for Postpartum Discharge

    Perceived Readiness for Discharge After Birth Scale-Form for New Mothers (PRDABS-FNM); This is a scale assessing the readiness for discharge by mothers' perceptions. It consists of four subdimensions and 23 items. The first item is answered dichotomously (yes/no). The items between 2 and 23 are calculated through the Likert type points ranging from 0 to 10. The subdimensions consisted of 1. Care skills, 2. Expected support; 3. Strength and ability to cope; 4. Stress control and knowledge of accessing help. The lowest and highest scores are 0 and 220. High scores indicate women's readiness for discharge.

    Measured: the post-test was applied in the first 36-40 hours in the postpartum period.

  2. Post-Test Anxiety Level

    State-Trait Anxiety Inventory (STAI): The scale which was developed in 1970 by Spielberger, Gorsuch, and Lushene is comprised of two parts for measuring state anxiety and trait anxiety. Each part has 20 items. The STAI-State is scored as per the severity level of the emotions and behaviors (1: Not at all, 2: Somewhat, 3: Moderately so, and 4: Very much so). In the STAI-State, there are ten reverse-scored items (Items 1, 2, 5, 8, 10, 11, 15, 16, 19, and 20). The items of the STAI-Trait are scored as per the expression frequency of the emotions and behaviors (1: Almost never, 2: Sometimes, 3: Often, and 4: Almost always). In the STAI-Trait, there are seven reverse-scored items (Items 21, 26, 27, 30, 33, 36, and 39). In the scoring, two separate keys are prepared for identifying the total weighted values of the straight-scored and reverse-scored items. These constant values are 50 and 35 respectively for the STAI-State and STAI-Trait.

    Measured: the post-test was applied in the first 36-40 hours in the postpartum period.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2021
  2. Study start4 Feb 2019
  3. Primary completion15 Jun 2019
  4. Study completion31 Aug 2019

Resources

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
The research is a single-blind randomized controlled experimental study. In view of the two groups called E and C, the total number of blocks was calculated as 20 blocks and the number of the participant mothers per block was calculated as 12 mothers, namely, 6 mothers for group E and 6 mothers for group C. Through MS Office Excel 2013, 13 numbers were randomly selected from among numbers from 1 to 20 (9, 17, 19, 4, 14, 3, 14, 1, 20, 16, 12, 8, 20, 2, and 5). By ensuring that each group has 78 mothers, a total of 156 mothers were assigned to experimental and control groups in equal numbers and homogeneously. In this context, the research was completed with the participation of 140 mothers, namely, 70 mothers in the experimental group and 70 mothers in the control group.
Masking
Single blind
Who is masked
Participant
Enrolment
140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04696991
Sponsor's protocol ID
P-K Met. Dis. and Anx.
Status last verified
Jan 2021
First submitted
4 Jan 2021
Last updated
6 Jan 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: all IPD that underlie results in a publication

Publications

  • McCarter-Spaulding D, Shea S. Effectiveness of Discharge Education on Postpartum Depression. MCN Am J Matern Child Nurs. 2016 May-Jun;41(3):168-72. doi: 10.1097/NMC.0000000000000236.

    PubMed 27128643
  • Yonemoto N, Dowswell T, Nagai S, Mori R. Schedules for home visits in the early postpartum period. Cochrane Database Syst Rev. 2017 Aug 2;8(8):CD009326. doi: 10.1002/14651858.CD009326.pub3.

    PubMed 28770973
  • Tiruneh GT, Shiferaw CB, Worku A. Effectiveness and cost-effectiveness of home-based postpartum care on neonatal mortality and exclusive breastfeeding practice in low-and-middle-income countries: a systematic review and meta-analysis. BMC Pregnancy Childbirth. 2019 Dec 18;19(1):507. doi: 10.1186/s12884-019-2651-6.

    PubMed 31852432
  • Ramos-Rincon JM, Sempere-Selva TS, Romero-Nieto M, Peris-Garcia J, Martinez-de la Torre G, Harris M, Fernandez-Sanchez J. Pecha Kucha presentations by medical students in Spain. Int J Med Educ. 2018 Sep 19;9:244-245. doi: 10.5116/ijme.5b92.52e3. No abstract available.

    PubMed 30244236
  • Saracoglu KT, Yilmaz M, Turan AZ, Kus A, Colak T, Saracoglu A. Pecha Kucha with Part-Task Training Improves Airway Management in Fresh Frozen Cadavers: A Case-Control Observational Study. Med Princ Pract. 2020;29(6):532-537. doi: 10.1159/000506597. Epub 2020 Feb 19.

    PubMed 32069469
  • Ramos-Gallardo G, Mecott-Rivera GA, Limon-Cervantes R, Garcia-Perez M, Rodriguez-Olivares E. How to Improve Speaking Skills in Plastic Surgery Training? Survey in Residents Participants in Pecha Kucha Contest. World J Plast Surg. 2018 May;7(2):166-170.

    PubMed 30083498
  • Pawluski JL, Lonstein JS, Fleming AS. The Neurobiology of Postpartum Anxiety and Depression. Trends Neurosci. 2017 Feb;40(2):106-120. doi: 10.1016/j.tins.2016.11.009. Epub 2017 Jan 24.

    PubMed 28129895
  • Nakic Rados S, Tadinac M, Herman R. Anxiety During Pregnancy and Postpartum: Course, Predictors and Comorbidity with Postpartum Depression. Acta Clin Croat. 2018 Mar;57(1):39-51. doi: 10.20471/acc.2017.56.04.05.

    PubMed 30256010
  • Gun Kakasci C, Durmaz A. A creative and practical approach to postpartum discharge education: Pecha Kucha training via smart phone. Health Care Women Int. 2022 Dec;43(12):1482-1502. doi: 10.1080/07399332.2022.2043860. Epub 2022 Jun 21.

    PubMed 35726861

Questions about this trial

What is this clinical trial studying?

A study testing The postpartum discharge education with PechaKucha Method. in people with Anxiety and Post Procedural Discharge, run by Aysegul Durmaz 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 13 inclusion and 13 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 6 Jan 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?

Pre-Test Readiness for Postpartum Discharge (time frame: the pretest was applied in the first 8-12 hours in the postpartum period.). 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?

On the ClinicalTrials.gov record for NCT04696991, which also lists 9 linked publications.

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 6 Jan 2021.

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