Birth, FirstNCT05471219
The Effect of Focus on Vaginal Examination Experience and Pain Level: a Randomized Controlled Trial
A study testing Primiparous pregnant women who will undergo vaginal examination by focusing on visual traces in people with Birth, First and Experience, Life, run by Dilek Yigit Vural at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Birth, First, Experience, Life, Pain
- What is being tested?
- Primiparous pregnant women who will undergo vaginal examination by focusing on visual traces
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 May 2021to 15 Oct 2021
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years and over,
- The gestational week is due,
- Able to speak and understand Turkish,
- Single and healthy fetus pregnancy,
- Primiparous,
- Head presentation,
Show all 14Show fewer
- 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.
Who cannot join
- Genito-urinary system infection,
- Having vaginismus,
- Pregnant women whose first vaginal examination was not performed by the researcher during labor.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara City Hospital/Gynecology and Obstetrics Hospital
Ankara, 06000
About this study
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
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.
Read more
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.
Read the 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
- Being tested
- Primiparous pregnant women who will undergo vaginal examination by focusing on visual traces
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primiparous pregnant women who will undergo vaginal examination by focusing on visual tracesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Çalışma grubu | Experimental | Primiparous pregnant women who will undergo vaginal examination by focusing on visual traces Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 15-minute time frame immediately after the vaginal exam
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2022
- Study start18 May 2021
- Primary completion15 Oct 2021
- Study completion15 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Birth, FirstStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dilek Yigit Vural
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dilek Yigit Vural, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05471219
- Sponsor's protocol ID
- D.2021-2022
- Status last verified
- Jul 2022
- First submitted
- 19 Jul 2022
- Last updated
- 2 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05471219
- Acronym / sponsor ID
- D.2021-2022
- Conditions
- Birth, First, Experience, Life, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Dilek Yigit VuralUniversity, hospital or other
- Study start
- 18 May 2021 (actual)
- Primary completion
- 15 Oct 2021 (actual)
- Study completion
- 15 Oct 2021 (actual)
- First posted
- 22 Jul 2022 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Çalışma grubu | Experimental | Other: Primiparous pregnant women who will undergo vaginal examination by focusing on visual tracesPrimiparous 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 18 years and over,
- The gestational week is due,
- Able to speak and understand Turkish,
- Single and healthy fetus pregnancy,
- Primiparous,
Key exclusion criteria (3 listed)
- Genito-urinary system infection,
- Having vaginismus,
- Pregnant women whose first vaginal examination was not performed by the researcher during labor.
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 |
|---|---|---|
| Primiparous pregnant women who will undergo vaginal examination by focusing on visual tracesInformed 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. | Other | Çalışma grubu |
Primary outcome
Visual Analogue Scale
Time frame: 15-minute time frame immediately after the vaginal exam
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.
The Women's Experiences of Vaginal Examinations in Labour Scale
Time frame: 15-minute time frame immediately after the vaginal exam
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.
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 2 Aug 2022.
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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 Primiparous pregnant women who will undergo vaginal examination by focusing on visual traces in people with Birth, First and Experience, Life, run by Dilek Yigit Vural 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 14 inclusion and 3 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 2 Aug 2022. 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?
Visual Analogue Scale (time frame: 15-minute time frame immediately after the vaginal exam). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Aug 2022.