NCT07403513

Brief Summary

Climate change can negatively impact women's health at different stages of life through environmental risks such as extreme temperatures, vector-borne diseases, and air pollution. Particularly during pregnancy, a period of intense physiological and psychosocial changes, climate change is reported to be associated with adverse maternal and infant outcomes such as spontaneous abortion, preterm birth, low birth weight, intrauterine growth retardation, and neonatal mortality. Therefore, identifying climate change-related risks during pregnancy, raising awareness of these risks, and developing preventative approaches are crucial for protecting maternal and fetal health. This study aims to evaluate the impact of a "Pregnancy and Climate Change" education program developed for pregnant women on their climate change awareness levels, anxiety levels regarding climate change, and hope levels for preventing climate change. The effectiveness of the education program will be determined by comparing the pre-test and post-test scores of the intervention and control groups. The research is designed as a randomized controlled experimental study with experimental and control groups in a pre-test-post-test configuration. The study population consists of all pregnant women who applied to the antenatal outpatient clinic of Zeynep Kamil Women and Children's Diseases Training and Research Hospital. The sample will consist of pregnant women who are 18 years of age and older, have a gestational age of 32 weeks or less, can speak and understand Turkish, and volunteer to participate in the study. Pregnant women with a history of psychiatric illness, systemic disease before or during pregnancy, or who experienced pregnancy complications such as preeclampsia and gestational diabetes will be excluded from the study. The sample size was calculated using the G\*Power 3.1 program based on the independent samples t-test. A moderate effect size (Cohen's d = 0.50), a 95% confidence level, and 80% statistical power were used. The analysis determined that a total of 128 pregnant women were needed, with at least 64 participants in each group. Considering possible sample losses, a 20% increase was made, and the study was planned with a total of 154 pregnant women, with 77 pregnant women in each group. Participants will be assigned to intervention (n=77) and control (n=77) groups using computer-assisted block randomization. The intervention group will receive approximately 60 minutes of face-to-face training on "Pregnancy and Climate Change" following a pre-test. The training will cover environmental risk factors, their effects on pregnancy, individual contraceptive approaches, and information aimed at raising awareness. Informative brochures will be distributed to participants after the training. Post-test data for the intervention group will be collected four weeks after the training. The control group will receive only a pre-test and a post-test four weeks later, without any training. Data will be collected through face-to-face interviews using a Personal Information Form, the Climate Change Anxiety Scale, the Climate Change Awareness Scale, and the Hope Scale for Preventing Climate Change. Data analysis will be performed using SPSS 25.0 software; descriptive statistics, t-test, ANOVA, chi-square test, and normal distribution analysis will be utilized.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
154

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 9, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 11, 2026

Completed
Last Updated

February 11, 2026

Status Verified

February 1, 2026

Enrollment Period

2 months

First QC Date

January 29, 2026

Last Update Submit

February 4, 2026

Conditions

Keywords

climate changepregnancymother healthhealth educationanxietyhope

Outcome Measures

Primary Outcomes (1)

  • Climate Change Awareness Scale

    Assesses participants' knowledge and understanding of climate change, environmental risks, and preventive behaviors. Measured using the Climate Change Awareness Scale (CCAS) at baseline and four weeks after the intervention.High scores on the scale indicate high awareness.

    6 Month

Secondary Outcomes (1)

  • Climate Change Anxiety Scale

    6 Month

Other Outcomes (1)

  • Hope for Climate Change Prevention Scale

    6 Month

Study Arms (2)

Climate Change Education Intervention Group

EXPERIMENTAL

The initiative group, consisting of 77 participants, will receive approximately 60 minutes of in-person training on "Pregnancy and Climate Change" following a pre-test. The training will cover environmental risk factors, their effects on pregnancy, methods of contraception, and individual awareness; informative brochures will be distributed to participants after the training. The final test data for the initiative group will be collected four weeks after the training.

Other: Climate Change Education

Control Group (No Climate Change Education)

NO INTERVENTION

The control group, consisting of 77 participants, will receive only a pre-test and a post-test four weeks later, without any training.

Interventions

The intervention group will receive approximately 60 minutes of in-person training on "Pregnancy and Climate Change" following the pre-test. The training will focus on environmental risks, their effects on pregnancy, and contraceptive approaches; an informative brochure will be provided at the end of the training. The final test measurements for the intervention group will be taken four weeks after the training.

Climate Change Education Intervention Group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant Women
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being pregnant
  • Being 18 years of age or older
  • Being at or below 32 weeks of gestation
  • Ability to speak and understand Turkish
  • Volunteering to participate in the study

You may not qualify if:

  • History of psychiatric illness or psychiatric treatment
  • Presence of any systemic disease before or during pregnancy
  • History of pregnancy-related complications, such as preeclampsia or gestational diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Health Sciences University Hamidiye Institute of Health Sciences

Istanbul, Üsküdar, 34668, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Health EducationAnxiety Disorders

Condition Hierarchy (Ancestors)

Adherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorMental Disorders

Study Officials

  • Melike DİŞSİZ, Associate Professor, PhD RN

    Istanbul Health Sciences University Hamidiye Faculty of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist Nurse, PhD Student

Study Record Dates

First Submitted

January 29, 2026

First Posted

February 11, 2026

Study Start

July 9, 2025

Primary Completion

September 1, 2025

Study Completion

January 1, 2026

Last Updated

February 11, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Individual participant data will be shared in a fully de-identified and anonymized format. Shared data will be used solely for scientific research purposes and cannot be linked to identifiable participants. Data will be made available upon request, following appropriate ethical and legal approvals.

Locations