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

NCT05471219 | Completed DMC

• 1 other identifier: D.2021-2022
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Birth, First; Experience, Life; Pain

Outcome Measures

Primary Outcomes (2)

• Visual Analogue Scale

  It is a scale used to measure perceived pain. In the form of a 0-10 cm ruler, one end of the scale indicates 0 painlessness and the other end 10 indicates the most severe pain intensity degree. The degree of pain intensity was evaluated by marking the perceived pain of the pregnant woman on the ruler.

  15-minute time frame immediately after the vaginal exam

• The Women's Experiences of Vaginal Examinations in Labour Scale

  The Vaginal Examination Experiences of Women in Labor Scale is a 5-point Likert-type scale consisting of 20 items. In the scale, 9 items (5, 10, 13, 14, 15, 16, 17, 19 and 20) are reverse scored. The scale consists of five sub-dimensions. For the sub-dimensions of the scale, the scores of the items in each sub-dimension were summed and the raw scores were divided by the number of items, and sub-dimension scores between 1-5 were obtained. These scores are multiplied by 20 to obtain a sub-dimension score between 20-100. A minimum of 20 points and a maximum of 100 points can be obtained from the scale. Accordingly, the higher the score of an item, the more satisfied the participant will be with the vaginal examination.

  15-minute time frame immediately after the vaginal exam

Study Arms (2)

Çalışma grubu

EXPERIMENTAL

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

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

Kontrol grubu

NO INTERVENTION

Primiparous pregnant women who will undergo vaginal examination with standard care

Interventions

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

Çalışma grubu

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Dilek Yigit Vural: lead

Study Sites (1)

Ankara City Hospital/Gynecology and Obstetrics Hospital

Ankara, 06000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Midwife

Study Record Dates

• First Submitted: July 19, 2022
• First Posted: July 22, 2022
• Study Start: May 18, 2021
• Primary Completion: October 15, 2021
• Study Completion: October 15, 2021
• Last Updated: August 2, 2022

Record last verified: 2022-07

Locations

TU (1)