NCT06688006

Brief Summary

Pregnant women are among the groups most affected by the negative health effects of climate change, such as low birth weight, preterm birth, premature rupture of membranes, stillbirth, gestational diabetes, gestational hypertension and preeclampsia, spontaneous abortion, malnutrition, respiratory illness and stress, depression, post-traumatic stress disorder. It can lead to adverse pregnancy outcomes, including psychological problems. Climate change education enables pregnant women to make informed decisions by raising their awareness and helps improve their ability to adapt to the negative effects of climate change. Health education for individuals and pregnant women uses methods such as demonstration, role-playing, screening, expression, question-answering, problem-solving, and short animated films. Short animated films, which are visual and auditory media and are an interesting method of health education, ensure that the information conveyed is stored in long-term memory. No studies were found in Turkey to determine pregnant women's awareness and hope regarding climate change or to increase their awareness and knowledge through education and short animated films. The creation of an original short animated film and its support through education show the difference of this study from other studies. Therefore, this study was planned based on the assumption that climate change education and short animated film would increase the awareness and hope of pregnant women. The purpose of this study is to investigate the effects of climate change education and short animated film on pregnant women's awareness and hope. This study was designed as a randomized controlled trial.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
288

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 14, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

February 26, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 18, 2025

Completed
Last Updated

July 23, 2025

Status Verified

July 1, 2025

Enrollment Period

1 month

First QC Date

November 12, 2024

Last Update Submit

July 18, 2025

Conditions

Keywords

climate changeshort animated film

Outcome Measures

Primary Outcomes (3)

  • Personality Information Form

    The personal information form is a questionnaire developed by the researchers based on the literature. The survey includes 13 questions on the introductory socio-demographic characteristics (age, education, etc.) of women and their husbands, 16 questions on the obstetric characteristics of women (gestational week, number of pregnancies, etc.), and 18 questions on climate change (Ha et al. 2018, Kısrık and Avcıbay Vurgeç 2022, Leung et al. 2023).

    Baseline (at the beginning of the study)

  • Climate Change Pregnant Awareness Scale

    The Climate Change Pregnant Awareness Scale is a 21-item scale developed by Kısrık and Avcıbay Vurgeç (2022) to assess pregnant women's awareness of the effects of climate change on maternal-fetal health. Each of the scale items is a 5-point Likert-type item as "1-I strongly disagree, 2-I partially disagree, 3-I am undecided, 4-I slightly agree, 5-I strongly agree". There is no reverse item in the scale. It consists of 3 subscales: General (items 1, 2, 3, 4, 7 and 8), Fetal (items 5, 6, 11, 12, 13, 14 and 15 and 16) and Maternal (items 9, 10, 17, 18, 19, 20 and 21). The score obtained for each sub-dimension indicates awareness of that sub-dimension. The minimum score for the total scale is 21 and the maximum is 105. As the total score increases, women's awareness of climate change increases. The overall Cronbach's alpha coefficient of the scale is 0.94.

    Baseline (at the beginning of the study)

  • Climate Change Pregnant Awareness Scale

    The Climate Change Pregnant Awareness Scale is a 21-item scale developed by Kısrık and Avcıbay Vurgeç (2022) to assess pregnant women's awareness of the effects of climate change on maternal-fetal health. Each of the scale items is a 5-point Likert-type item as "1-I strongly disagree, 2-I partially disagree, 3-I am undecided, 4-I slightly agree, 5-I strongly agree". There is no reverse item in the scale. It consists of 3 subscales: General (items 1, 2, 3, 4, 7 and 8), Fetal (items 5, 6, 11, 12, 13, 14 and 15 and 16) and Maternal (items 9, 10, 17, 18, 19, 20 and 21). The score obtained for each sub-dimension indicates awareness of that sub-dimension. The minimum score for the total scale is 21 and the maximum is 105. As the total score increases, women's awareness of climate change increases. The overall Cronbach's alpha coefficient of the scale is 0.94.

    six weeks after education

Secondary Outcomes (2)

  • Hope for Preventing Climate Change Scale (HOC)

    Baseline (at the beginning of the study)

  • Hope for Preventing Climate Change Scale (HOC)

    six weeks after education

Study Arms (2)

Experimental: climate change short animation film

EXPERIMENTAL

Before enrolling the pregnant women in the intervention group, the informed consent form, the personal information form, the climate change awareness scale for pregnant women and the climate change hope scale (pre-test) will be completed. The researcher will then give a 30-minute training presentation on the climate crisis to the pregnant women individually in the conference room on the third floor of the maternity hospital. Two weeks after the training, the worker will open a meeting session via Microsoft Teams or Google Meet, and a short animated film will be watched on this platform as a reminder. Four weeks after the viewing of the short animation film, another meeting session will be set up via Microsoft Teams or Google Meet and the link to the survey form will be shared online and the final evaluations (post-test - questions on climate change, climate change awareness scale and hope scale for preventing climate change) will be carried out.

Other: climate change short animation film

Control

NO INTERVENTION

No application will be made to the pregnant women in the control group, and the informed consent form, personal information form, Climate Change Pregnancy Awareness Scale and Climate Change Prevention Hope Scale (pre-test) will be completed at the first interview. During this time, a sign will be hung on the door to prevent anyone from entering or leaving the room. Six weeks after the first interview, the link to the survey form (Questions about Climate Change, Climate Change Pregnant Awareness Scale and Climate Change Prevention Hope Scale) will be shared with the pregnant women via Microsoft Teams or Google Meet and their final evaluation (post-test) will be conducted. A video interview will be conducted with the control group in a Microsoft Teams or Google Meet meeting to ensure that real people completed the form. At the end of the study, an educational booklet and a short animated film on climate change will be sent online.

Interventions

For the short animated film, a scenario will be created that describes climate change, risk factors that threaten human health as a result of climate change, adverse health effects of climate change, adverse effects on maternal and foetal health, precautions to be taken to protect against and adapt to the adverse effects of climate change. In the short animation film, visual materials will be created that show the adverse effects of climate change by using developing technology. The created scenario will be prepared as a two-dimensional (2D) animation film with the support of Selçuk University SERATEM (Selçuk University Radio and Television Application Center). All lines, colours, decorations and characters used in the creation phase of the short animation film will be determined by the researchers. Once the drawing and animation phases are complete, the voice-over actors will be selected after a further review. The short animated film should be about 2-3 minutes long.

Experimental: climate change short animation film

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant women aged 18-49,
  • Have a singleton pregnancy,
  • Have at least a primary school education and are able to communicate,
  • Have no vision or hearing problems
  • and use an online communication platform (Microsoft Teams or Google Meet)

You may not qualify if:

  • Pregnant women who conceived with assisted reproductive techniques and have high-risk pregnancies
  • Pregnant women who received training during the study but did not watch the short animated film on Microsoft Teams and Google Meet,
  • who gave birth,
  • who wanted to leave

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Konya City Hospital

Konya, 42130, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
The generated numbers are written on small pieces of paper, folded and placed in a small box. The box will be given to the pregnant woman by a midwife not involved in the study and she will be asked to draw a number. This will determine whether the pregnant woman is in the intervention group or the control group. This reduces the possibility of bias in the study. During the data collection process of the study, the researcher will know which group the pregnant women are in, but the pregnant women will not know which group they are in. A single-blind method will be used. The statistics of the trial will be done by a statistician who is not involved in the trial. The intervention and control groups will be given a code or colour so that the statistician does not know which group the data belong to.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: To ensure randomization in the study, the blocks will first be created by stratifying the pregnant women according to their age and level of education using the stratified sampling method, and then it will be decided whether the pregnant women in the groups will be in the intervention or control group using simple randomization. Then, a table of random numbers between 1-288 will be generated using the Random.org website with simple random sampling method (https://www.random.org/sequences/).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Dr.

Study Record Dates

First Submitted

November 12, 2024

First Posted

November 14, 2024

Study Start

February 26, 2025

Primary Completion

March 30, 2025

Study Completion

July 18, 2025

Last Updated

July 23, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations