Clinical trial NCT06688006: Climate Change Education and a Short Animated Film on Pregnant Women's Awareness and Hope
Official title: The Effect of Climate Change Education and a Short Animated Film on Pregnant Women's Awareness and Hope Levels: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Awareness
Pregnancy Related
Hope
Keywords: climate change
short animated film
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2024-11-14
Enrollment: 288
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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/).
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: The population of the study is all pregnant women in the second and third trimesters who present to the antenatal clinic of Konya City Hospital. The sample of the study consists of pregnant women who meet the criteria for inclusion in the study and agree to participate in the study after being informed about the study. G-Power 3.1.9.7, based on the Hope Scale for the Prevention of Climate Change score average (56.14±9.75), of which the study sample size is known. The program calculated the 3-unit difference by choosing a power of 0.85, an effect size of 0.30, an alpha level of 0.05, and a two-sided hypothesis option, and aimed to reach a total of 262 participants, 131 in the intervention group and 131 in the control group. Considering the data loss, it was planned to conduct the study with 276 pregnant women, which is 5% more than the set sample number. Research data: collected on a self-report basis using the "Informed Consent Form"," the "Personal Information Form"," the "Pregnant Awareness Scale for the Effects of Climate Change on Maternal Fetal Health," and the "Climate Change Hope Scale"." Pre-tests with questionnaires will be conducted at the first interview with the pregnant women who were randomly assigned to the intervention and control groups. An educational brochure on climate change will be given to the pregnant women in the intervention group, and a presentation will be given by the researcher. Two weeks after the training, a short animated film will be viewed via WhatsApp as a reminder. Two weeks after watching the short animated film, the link to the survey form will be shared online via WhatsApp, and final evaluations will be conducted. Pregnant women who are part of the control group will not undergo any intervention application. Four weeks after the first meeting, a link to the survey form will be shared via WhatsApp and final evaluations will be conducted. After completion of the study, the educational brochure and the short animated film on climate change will be sent online to the pregnant women in the control group.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Personality Information Form
timeFrame: Baseline (at the beginning of the study)
measure: Climate Change Pregnant Awareness Scale
timeFrame: Baseline (at the beginning of the study)
measure: Climate Change Pregnant Awareness Scale
timeFrame: six weeks after education
Secondary outcomes:
measure: Hope for Preventing Climate Change Scale (HOC)
timeFrame: Baseline (at the beginning of the study)
measure: Hope for Preventing Climate Change Scale (HOC)
timeFrame: six weeks after education
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Konya City Hospital
Study officials:
References: