Motivational InterviewNCT06380634
The Effectiveness of Motivational Interviewing in Reducing the Use of Household Chemicals and Personal Care Products During Pregnancy
A study testing Experimental group- Motivational Interview in people with Motivational Interview and Cosmetic Product Causing Toxic Effect, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 43 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Motivational Interview, Cosmetic Product Causing Toxic Effect
- What is being tested?
- Experimental group- Motivational Interview
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Jan 2023to 20 Feb 2024
- 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 20 to 43 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gebelikte Ev İçi Kimyasallar ve Kişisel Bakım Ürünlerinin Kullanımını Azaltmada Motivasyonel Görüşmenin Etkinliği
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.
Read the detailed description
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.
- Being tested
- Experimental group- Motivational Interview
- Keywords
- Household Product, Midwifery, Pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental group- Motivational InterviewBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group (Randomize) | Experimental | 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. Receives: Behavioral: Experimental group- Motivational Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation Form for Use of Domestic Chemicals and Personal Care Products
In this form prepared by the researcher in line with the literature, the use of cosmetic products was asked with 41 product names in five main categories such as rinsed products, products applied to the skin and not rinsed, products applied to the hair, make-up products, intimate care products; Household chemicals are asked with 12 product names (Ashrap et al., 2018; Ingle et al., 2019; Preston et al., 2021; Fruh et al., 2022; Deierlein et al., 2022). The personal care product usage frequency of the experimental and control groups was asked in a 5-point Likert type at the pre-test and post-test, and then the difference in pre-test and post-test product usage was categorized as increasing, remaining the same or decreasing.
Measured: 1 year
Self Efficacy Competence Scale
On a five-point Likert-type scale consisting of 23 items, each item is marked as 1-does not describe me at all, 2-describes me a little, 3-undecided, 4-describes me well, 5-describes me very well.
Measured: 1 year
Endocrine Disruptors Attitude Scale
The scale consists of 21 items. The endocrine disruptors attitude scale has two sub-dimensions: consumer behavior and nutrition and hygiene. The scale was prepared as a five-point Likert type as "I completely agree", "I agree", "I am undecided", "I disagree", "I strongly disagree".
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start23 Jan 2023
- Primary completion31 Dec 2023
- Study completion20 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Motivational InterviewStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The research was conducted in a prospective pre-test, post-test based randomized controlled experimental research design.
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nazli Yalcinbas, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06380634
- Sponsor's protocol ID
- NYalcinbas
- Status last verified
- Apr 2024
- First submitted
- 12 Mar 2024
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33957140Deierlein 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.
PubMed 35565038Ashrap 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.
PubMed 30316544Fruh 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.
PubMed 35469886Ingle 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.
PubMed 31574449Akman NY, Ozcan NK. Can exposure to chemical products be reduced during pregnancy? BMC Pregnancy Childbirth. 2026 Apr 7;26(1):537. doi: 10.1186/s12884-026-08987-5.
PubMed 41942949
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gebelikte Ev İçi Kimyasallar ve Kişisel Bakım Ürünlerinin Kullanımını Azaltmada Motivasyonel Görüşmenin Etkinliği
- ClinicalTrials.gov ID
- NCT06380634
- Acronym / sponsor ID
- NYalcinbas
- Keywords
- Household Product, Midwifery, Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 23 Jan 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 20 Feb 2024 (actual)
- First posted
- 24 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The research was conducted in a prospective pre-test, post-test based randomized controlled experimental research design.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group (Randomize) | Experimental | Behavioral: Experimental group- Motivational InterviewThe 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. |
Who may qualify
- Ages
- 20 to 43 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental group- Motivational InterviewPregnant 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. | Behavioural | Experimental Group (Randomize) |
Primary outcome
Evaluation Form for Use of Domestic Chemicals and Personal Care Products
Time frame: 1 year
In this form prepared by the researcher in line with the literature, the use of cosmetic products was asked with 41 product names in five main categories such as rinsed products, products applied to the skin and not rinsed, products applied to the hair, make-up products, intimate care products; Household chemicals are asked with 12 product names (Ashrap et al., 2018; Ingle et al., 2019; Preston et al., 2021; Fruh et al., 2022; Deierlein et al., 2022). The personal care product usage frequency of the experimental and control groups was asked in a 5-point Likert type at the pre-test and post-test, and then the difference in pre-test and post-test product usage was categorized as increasing, remaining the same or decreasing.
Self Efficacy Competence Scale
Time frame: 1 year
On a five-point Likert-type scale consisting of 23 items, each item is marked as 1-does not describe me at all, 2-describes me a little, 3-undecided, 4-describes me well, 5-describes me very well.
Endocrine Disruptors Attitude Scale
Time frame: 1 year
The scale consists of 21 items. The endocrine disruptors attitude scale has two sub-dimensions: consumer behavior and nutrition and hygiene. The scale was prepared as a five-point Likert type as "I completely agree", "I agree", "I am undecided", "I disagree", "I strongly disagree".
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Background: PubMed 33957140Preston 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.
- Background: PubMed 35565038Deierlein 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.
- Background: PubMed 30316544Ashrap 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.
- Background: PubMed 35469886Fruh 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.
- Background: PubMed 31574449Ingle 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.
- Derived from this study: PubMed 41942949Akman NY, Ozcan NK. Can exposure to chemical products be reduced during pregnancy? BMC Pregnancy Childbirth. 2026 Apr 7;26(1):537. doi: 10.1186/s12884-026-08987-5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental group- Motivational Interview in people with Motivational Interview and Cosmetic Product Causing Toxic Effect, run by Istanbul University - Cerrahpasa 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 5 inclusion and 6 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 24 Apr 2024. 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?
Evaluation Form for Use of Domestic Chemicals and Personal Care Products (time frame: 1 year). The study lists 3 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 NCT06380634, which also lists 6 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 24 Apr 2024.