Gebelikte Ev İçi Kimyasallar ve Kişisel Bakım Ürünlerinin Kullanımını Azaltmada Motivasyonel Görüşmenin Etkinliği
Phase: NA
Conditions: Motivational Interview, Cosmetic Product Causing Toxic Effect
Sponsor: Istanbul University - Cerrahpasa

TR Istanbul University-Cerrahpaşa ID: NYalcinbas
The Effectiveness of Motivational Interviewing in Reducing the Use of
Household Chemicals and Personal Care Products During Pregnancy
Study Protocol: February 5, 2024
Clinical Trial Number: NCT ID not yet assigned

WORKING PROTOCOL
Title / Date
The Effectiveness of Motivational Interviewing in Reducing the Use of
Household Chemicals and Personal Care Products During Pregnancy
Approval of the education
officer of the unit( s ) where
the study will be carried out.
Sile State Hospital Gynecology and Obstetrics Polyclinics
Name and surname of the
responsible investigator,
e-mail address, mobile
phone,
signature
Prof. Dr. Neslihan Özcan
neslihan_keser@hotmail.com
05326341255
Assistant researcher name
and surname, e-mail
address,
mobile phone, signature
Nazlı Yalçınbaş
nazli.yalcinbas@ogr.iuc.edu.tr
05360363618
Assistant researcher name
and surname, e-mail
address,
mobile phone, signature
Financial agreements
between the sponsor,
principal
investigator or research site

main purpose,
Secondary purpose, if
any hypothesis ( es )
Purpose: The aim of the study is to raise awareness among women
about the negative effects of household chemicals and personal
care products that they frequently use in their daily lives, on
themselves and their babies, through motivational interviewing,
and to provide positive behavioral change in women through
motivational interviewing.
Hypotheses:
H0: Motivational interviewing is not effective in reducing the use of
domestic chemicals and personal care products by pregnant women.
H1: Motivational interviewing is effective in reducing pregnant women's
use of domestic chemicals and personal care products.
Medical condition/area
of treatment
investigated
In this study; 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. No treatment will be
applied.
of the population to be
examined (acceptance and
exclusion criteria, age range
by gender, termination
criteria of the study when
necessary) identification of
subgroups, if any )
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.

Independent variables: Demographic characteristics of women,
obstetric characteristics, motivational interviewing
Dependent variables: Household Chemicals and Personal Care Products
Use Evaluation Form, Self-Efficacy Competence Scale, and Endocrine
Disruptors Attitude Scale.
Design features (clinical
trial / retrospective study /
case) sample size,
determination of the
number of centers, study
duration,
if any randomization
method and its
importance
Blindness method and its
importance, if any
The research was conducted in a prospective pre-test, post-test based
randomized controlled experimental research design.Using the
G*Power (3.0.10) Program, 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). 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.
Address of the clinic,
laboratory, other medical
units and institutions, if
any,
from cases , processing
of data/keeping
records,
evaluation criteria,
quality control and
quality assurance
No samples will be taken from the pregnant women forming the sample
group.
Statistical method to be applied
Analysis of the research data was done with SPSS version 23.0 package
program. Descriptive statistics of continuous variables in the study were
shown with mean, standard deviation, minimum and maximum values, and
descriptive statistics of categorical variables were shown with frequency
and percentage. Normality analysis was performed before making
comparisons between variables. Since skewness and kurtisos values are
between -2 and +2, it is assumed that the variables have a normal
distribution (George and Mallery, 2010). Therefore, parametric tests were
used in the analyses. While the score differences of the experimental and
control groups between groups and time were examined with the t test, the
change between groups according to time was examined using mixed
pattern analysis of variance - ANOVA (generalized linear model). Cohen-d
effect value was used for change over time and between groups, and eta
squared (η2) value was used for change on the group*time axis. Eta

squared is considered as low potency of 0.01, medium potency of 0.06,
and high potency of 0.14 and above.

List of publications: at
least 2 (copies will be on
file)
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.
PubMed
ID: 30316544
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.
PubMed ID:
35565038

Summary of findings from
studies conducted /
supporting information for
this study
in 2022, Deierlein et al. Women reported use of personal care
and household cleaning products within the previous month,
changes in antibacterial product use, receipt of healthcare
provider advice, and opinions on environmental chemicals (n
= 320). On average, women used 15 personal care products
and 7 household cleaning products. Results from this study
suggest that women may have increased their product use
during the pandemic (Deierlein, L. et al, 2022).
in 2018, Ashrap et al. 1003 pregnant women between years
2010 and 2016 from prenatal clinics and collected urine
samples and questionnaire data on personal care product
use at up to three separate visits, between 16 and 28 weeks
gestation. A decreasing temporal trend was statistically
signiﬁcant for urine concentrations of BPA during the study
period, while the BPA substitute BPS showed an increasing
temporal trend. Signiﬁcant and positive associations were
found between biomarker concentrations with the products
use in the past 48-h (soap, sunscreen, lotion, cosmetics).
There was an increasing trend of triclocarban/triclosan
urinary concentrations with increased concentrations of
triclocarban/triclosan listed as the active ingredient in the bar
soap/liquid soap products reported being used.Results
suggest several potential exposure sources to triclocarban,
phenols, and parabens in this population and may help inform
targeted approaches to reduce exposure (Ashrap P. et al,
2018).

Publication policy
The research will be carried out in line with universal ethical principles.
In order to conduct the research, permission was first obtained from
Istanbul University-Cerrahpaşa Non-Interventional Ethics Committee.
Participants in the study were given information in the Informed
Volunteer Consent form, and their verbal and written consent was
obtained. The monitoring and supervision of the study was carried out
by the responsible researcher and the thesis advisor.