The Effect of Using Music and Natural Landscape Paintings on Pain Level, Anxiety and Analgesic Use of Women During HSG

NCT ID: NCT05712954

Last Updated: 2023-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-13

Study Completion Date

2023-07-31

Brief Summary

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The study was planned as a randomized controlled study in order to evaluate the use of music and natural scenery paintings in women who underwent HSG procedure, their pain level, anxiety and post-procedure analgesic use.

Detailed Description

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The universe of the research; Women who apply to Dicle University Hospital's Obstetrics and Gynecology Polyclinic will be recommended to have an HSG.

Sample of the research:

Women who applied to the Dicle University Hospital Obstetrics and Gynecology Outpatient Clinic and recommended to have an HSG will participate in the study.

In the calculation of the sample size of the research, in the calculation made in line with the data taken from the reference studies; The sample size was used at the 95% confidence interval, the effect size was 0.80, and the alpha was 0.05, and it was seen that at least 29 individuals should be included in each group.

Application of Research The study was planned to be conducted on women who were recommended to have an HSG, who applied to the Dicle University Hospital Obstetrics and Gynecology Clinic between January 2022 and July 2023 in a randomized controlled manner. The Socio-Demographic Data Questionnaire, Visual Pain Scale, State-Trait Anxiety Inventory, and the Socio-Demographic Data Questionnaire, prepared by the researcher for the women who were selected in accordance with the sample selection criteria and accepted to be a participant, in line with the recommendations of the academicians specialized in the field of Gynecology and Gynecology Nursing. Analgesia Follow-up Form will be applied.

After the control group study is completed, the case group study will begin. The reason why the control and case groups were not studied at the same time was because it was thought that women saw each other and would be affected by each other.

In the control group, only the pre-test before the procedure, the post-test after the procedure and the use of analgesics within 24 hours after the HSG will be questioned with data collection tools and no attempt will be made.

Case groups will be pre-tested before the procedure, they will be listened to music or shown pictures of natural landscapes during the procedure, and after the procedure is completed, the post-test will be applied and 24 hours after the procedure, they will be contacted and questioned whether they use analgesics.

Conditions

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Hysterosalpingography Anxiety Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A randomized controlled trial model with pretest-posttest control group
Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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control group

The study will start with the women in the control group. The women in the control group, who were selected in accordance with the sample selection criteria and agreed to be a participant, will be given data collection tools for the pre-test on the day of the procedure and no intervention will be made other than the counseling given at the hospital. VAS and State-Trait Anxiety Inventory will be applied after the procedure. After 24 hours, the women will be reached and questioned whether they use analgesics.

Group Type NO_INTERVENTION

No interventions assigned to this group

music group

The women in the 1st group will be pre-tested with data collection tools before the HSG, then after they are taken to the table, headphones will be put on and music will be played. VAS and State-Trait Anxiety Inventory will be applied after the procedure. After 24 hours, the women will be reached and questioned whether they use analgesics. After the women in this group are completed, the 2nd group will be started.

Group Type EXPERIMENTAL

music group

Intervention Type OTHER

music

video group

2\. The women in the group will be pre-tested with data collection tools before the HSG, and after they are taken to the table, a video with natural landscape pictures prepared by the researcher will be opened on the iPad. VAS and State-Trait Anxiety Inventory will be applied after the procedure. After 24 hours, the women will be reached and questioned whether they use analgesics.

Group Type EXPERIMENTAL

video group

Intervention Type OTHER

video

Interventions

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music group

music

Intervention Type OTHER

video group

video

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* In the research be over 18 years old
* At least primary school graduate
* Not have a diagnosed psychiatric illness
* Not having mental deficiency and communication problems
* No drug sensitivity or allergy
* Not having received infertility treatment before
* Being diagnosed with primary infertility

Exclusion Criteria

* To be illiterate be under the age of 18
* Having a diagnosed psychiatric illness
* Mental disability and communication problems
* Having drug sensitivity and allergy
* Being diagnosed with secondary infertility
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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ŞERİVAN KARAKUT

OTHER

Sponsor Role lead

Responsible Party

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ŞERİVAN KARAKUT

lecturer

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Şerivan

Gaziantep, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Facility Contacts

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şerivan karakut

Role: primary

05529422826

ümran sevil

Role: backup

0554 911 50 26

Other Identifiers

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2022/126

Identifier Type: -

Identifier Source: org_study_id

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