The Effectiveness of Motivational Interviewing in Reducing the Use of Household Chemicals and Personal Care Products During Pregnancy

NCT ID: NCT06380634

Last Updated: 2024-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-23

Study Completion Date

2024-02-20

Brief Summary

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Objective: The aim of the study is to examine the effect of motivational interviewing on reducing the use of household chemicals and personal care products during pregnancy.

Detailed Description

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Introduction :During pregnancy, women are exposed to cosmetic products and household chemicals frequently used in daily life.

Method: The research was conducted in a prospective pre-test, post-test based randomized controlled experimental research design.The sample of the study consisted of 140 pregnant women who applied to the Ministry of Health Istanbul Provincial Health Directorate and Sile State Hospital Gynecology and Obstetrics Polyclinics between May and December 2023, volunteered to participate in the study and met the inclusion criteria.

Firstly, the Informed Consent Form and Introductory Information Form were applied to the women, then the Personal Care Products Use Evaluation Form, Self-Efficacy Scale and Endocrine Disruptors Attitude Scale were applied. The experimental group was informed about the motivational interviewing technique and an appropriate plan was made. After the interviews, the Personal Care Products Use Evaluation Form, Self-Efficacy Scale and Endocrine Disruptors Attitude Scale were re-administered.

Conditions

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Motivational Interview Cosmetic Product Causing Toxic Effect

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

The research was conducted in a prospective pre-test, post-test based randomized controlled experimental research design.
Primary Study Purpose

SCREENING

Blinding Strategy

NONE

The groups were randomized into 2 groups using a web-based randomization program (http://www.randomizer.org). The researcher included pregnant women who met the inclusion criteria in the outpatient clinics on certain days of the week, in accordance with the randomization process.

Study Groups

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Experimental Group (Randomize)

The sample size was determined as at least 64 people for each of the experimental and control groups, with 80% power, 0.05 margin of error and 0.5 effect level. Considering the possibility of data loss later on, 70 pregnant women (140 in total) were included in each group. The groups were randomized into 2 groups using a web-based randomization program (http://www.randomizer.org). 357 pregnant women were evaluated for suitability for the study. 68 women did not meet the inclusion criteria and 149 women were not included because they did not agree to participate in the study. The pre-test of the study was completed with 70 experimental and 70 control groups (140 in total), and the post-test was completed with a total of 130 people, 69 experimental and 61 control groups.

Group Type EXPERIMENTAL

Experimental group- Motivational Interview

Intervention Type BEHAVIORAL

Pregnant women who applied to the gynecology clinic and met the inclusion criteria were informed about the study. Those who agreed were informed about the purpose of the research. Firstly, the Informed Volunteer and Introductory Information Form was applied to the women, then the Personal Care Products Use Evaluation Form, Self-Efficacy Scale and Endocrine Disruptors Attitude Scale were applied. Then, the experimental group was informed about the motivational interviewing technique. A total of 3 interviews were held. The final test was made at the fourth meeting.

Interventions

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Experimental group- Motivational Interview

Pregnant women who applied to the gynecology clinic and met the inclusion criteria were informed about the study. Those who agreed were informed about the purpose of the research. Firstly, the Informed Volunteer and Introductory Information Form was applied to the women, then the Personal Care Products Use Evaluation Form, Self-Efficacy Scale and Endocrine Disruptors Attitude Scale were applied. Then, the experimental group was informed about the motivational interviewing technique. A total of 3 interviews were held. The final test was made at the fourth meeting.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Being at least 18 years old
* Education level must be at least primary school
* Speaking Turkish
* Having a single pregnancy between the 8th and 40th weeks
* Using household chemicals and personal care products (any product at least once a week)

Exclusion Criteria

* Having a psychiatric illness that prevents communication,
* Having a chronic serious physical health problem
* Termination of pregnancy for any reason
* Having a risky pregnancy (preeclampsia, threat of premature birth)
* Intrauterine growth retardation, having a pregnancy with fetal anomalies
* Working in a job that requires heavy use of chemicals, such as hairdresser, dry cleaner, beautician.
Minimum Eligible Age

20 Years

Maximum Eligible Age

43 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Istanbul University - Cerrahpasa

OTHER

Sponsor Role lead

Responsible Party

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Nazli Yalcinbas

midwife

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Istanbul University Cerrahpasa

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Preston EV, Chan M, Nozhenko K, Bellavia A, Grenon MC, Cantonwine DE, McElrath TF, James-Todd T. Socioeconomic and racial/ethnic differences in use of endocrine-disrupting chemical-associated personal care product categories among pregnant women. Environ Res. 2021 Jul;198:111212. doi: 10.1016/j.envres.2021.111212. Epub 2021 May 3.

Reference Type BACKGROUND
PMID: 33957140 (View on PubMed)

Deierlein AL, Grayon AR, Zhu X, Sun Y, Liu X, Kohlasch K, Stein CR. Personal Care and Household Cleaning Product Use among Pregnant Women and New Mothers during the COVID-19 Pandemic. Int J Environ Res Public Health. 2022 May 6;19(9):5645. doi: 10.3390/ijerph19095645.

Reference Type BACKGROUND
PMID: 35565038 (View on PubMed)

Ashrap P, Watkins DJ, Calafat AM, Ye X, Rosario Z, Brown P, Velez-Vega CM, Alshawabkeh A, Cordero JF, Meeker JD. Elevated concentrations of urinary triclocarban, phenol and paraben among pregnant women in Northern Puerto Rico: Predictors and trends. Environ Int. 2018 Dec;121(Pt 1):990-1002. doi: 10.1016/j.envint.2018.08.020. Epub 2018 Oct 11.

Reference Type BACKGROUND
PMID: 30316544 (View on PubMed)

Fruh V, Preston EV, Quinn MR, Hacker MR, Wylie BJ, O'Brien K, Hauser R, James-Todd T, Mahalingaiah S. Urinary phthalate metabolite concentrations and personal care product use during pregnancy - Results of a pilot study. Sci Total Environ. 2022 Aug 20;835:155439. doi: 10.1016/j.scitotenv.2022.155439. Epub 2022 Apr 22.

Reference Type BACKGROUND
PMID: 35469886 (View on PubMed)

Ingle ME, Watkins D, Rosario Z, Velez Vega CM, Huerta-Montanez G, Calafat AM, Ospina M, Cordero JF, Alshawabkeh A, Meeker JD. The association of urinary organophosphate ester metabolites and self-reported personal care and household product use among pregnant women in Puerto Rico. Environ Res. 2019 Dec;179(Pt A):108756. doi: 10.1016/j.envres.2019.108756. Epub 2019 Sep 23.

Reference Type BACKGROUND
PMID: 31574449 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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NYalcinbas

Identifier Type: -

Identifier Source: org_study_id

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