Clinical trial NCT05471219: The Effect of Focus on Vaginal Examination Experience and Pain Level: a Randomized Controlled Trial
Official title: THE EFFECT OF FOCUS APPLICATION DURING THE FIRST VAGINAL EXAMINATION IN TRAVEL ON THE VAGINAL EXAMINATION EXPERIENCE AND PAIN LEVEL OF PREGNANT PREGNANCY: A RANDOMIZED CONTROLLED STUDY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Birth, First
Experience, Life
Pain
Lead sponsor: Kahramanmaras Sutcu Imam University
Sponsor class: OTHER
First posted: 2022-07-22
Enrollment: 102
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Vaginal examination contains many negative emotions such as pain, fear, stress, and discomfort for women. When the literature was examined, no study was found in which the focus method was used to reduce or eliminate the feelings that cause negative emotions in women in the vaginal examination experience. For this reason, our research will be a first in the literature and it is thought that it will contribute to the field. In this context, it is assumed that the focusing behavior based on the door control theory will reduce the pain level of primiparous women who will have a vaginal examination for the first time in labor, positively affect the vaginal examination experience and experience a positive birth. In the research; Ho hypothesis: Focus has no effect on the vaginal examination experience of pregnant women.

Hypothesis H1: Focus has an impact on the vaginal examination experience of pregnant women.

Ho hypothesis: Focus has no effect on vaginal examination pain level of pregnant women.

Hypothesis H1: Focus has an effect on the vaginal examination pain level of pregnant women.

It was aimed to examine the effect of focusing on the first vaginal examination experience and pain level of primiparous women in labor by establishing hypotheses.

Detailed description: Vaginal examination before and during labor may cause negative feelings in women and adversely affect the birth. Distraction attempts to be made during the examination process can help the pregnant woman both self-confidence and take the first step towards a positive birth. This study was conducted to examine the effect of the focus applied during the first vaginal examination in labor on the vaginal examination experience and pain level of primiparous pregnant women. The study was conducted in a randomized controlled clinical trial design with primiparous women who applied to give birth in Ankara City Hospital Gynecology clinic between June and November 2021. 102 (study: 51, control: 51) women determined by the G\*Power 3.1 program were included in the research sample. Research data were collected through an introductory information form, a visual comparison scale, and a scale of women's expressions of vaginal examination in labor. Data were analyzed with IBM SPSS V23. Compliance with normal distribution was examined by Shapiro-Wilk and Kolmogorov-Smirnov tests, and when comparing normally distributed data in paired groups, independent two-sample t-test was used, and when comparing non-normally distributed data, Mann Whitney U Test was used. One-Way Analysis of Variance was used to compare the normally distributed data in the three groups, the Kruskal Wallis Test was used to compare the non-normally distributed data, and the Chi-Square Test was used to compare the categorical data. Spearman's rho correlation coefficient was used to examine the relationship between non-normally distributed variables and scale scores. Linear Regression Analysis was used to determine the independent variables affecting the scale score and VAS score. The results are presented as frequency (percentage) for categorical variables, mean ± standard deviation and median (minimum - maximum) for quantitative variables.

Eligibility criteria: Inclusion Criteria:

* 18 years and over,
* The gestational week is due,
* Able to speak and understand Turkish,
* Single and healthy fetus pregnancy,
* Primiparous,
* Head presentation,
* No diagnosis of risky pregnancy,
* Not allergic to latex,
* Having a vaginal examination for the first time after being admitted to the TDL service,
* In the latent phase (examination between 0-5 cm when applying to the emergency department (WHO, 2018))
* No communication problem,
* Does not have a mental illness,
* No premature rupture of membranes,
* Pregnant women who agreed to participate in the study.

Exclusion Criteria:

* Genito-urinary system infection,
* Having vaginismus,
* Pregnant women whose first vaginal examination was not performed by the researcher during labor.

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: 15-minute time frame immediately after the vaginal exam
measure: The Women's Experiences of Vaginal Examinations in Labour Scale
timeFrame: 15-minute time frame immediately after the vaginal exam
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital/Gynecology and Obstetrics Hospital
Study officials:
References: