The Effect of Focus on Vaginal Examination Experience and Pain Level: a Randomized Controlled Trial

NCT ID: NCT05471219

Last Updated: 2022-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-18
• Study Completion Date: 2021-10-15

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.

Conditions

Birth, First; Experience, Life; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Çalışma grubu

Primiparous pregnant women who will undergo vaginal examination by focusing on visual traces

Group Type: EXPERIMENTAL

Primiparous pregnant women who will undergo vaginal examination by focusing on visual traces

Intervention Type: OTHER

Informed consent was obtained from the mothers to take pictures of newborns who were delivered in the delivery room, routinely cared for, dressed and breastfed by the researcher. A 10-minute visual track was created to be turned into a slide from approximately 70 photos. Vaginal examination was performed between the 4th and 6th minutes while focusing on this visual trace.

Kontrol grubu

Primiparous pregnant women who will undergo vaginal examination with standard care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Primiparous pregnant women who will undergo vaginal examination by focusing on visual traces

Informed consent was obtained from the mothers to take pictures of newborns who were delivered in the delivery room, routinely cared for, dressed and breastfed by the researcher. A 10-minute visual track was created to be turned into a slide from approximately 70 photos. Vaginal examination was performed between the 4th and 6th minutes while focusing on this visual trace.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Dilek Yigit Vural

OTHER

Sponsor Role: lead

Responsible Party

Dilek Yigit Vural

Midwife

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Ankara City Hospital/Gynecology and Obstetrics Hospital

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

D.2021-2022

Identifier Type: -

Identifier Source: org_study_id