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

NCT05712954 | Unknown DMC

• 1 other identifier: 2022/126
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hysterosalpingography; Anxiety; Pain

Keywords

hsg; music; natural landscape; anxiety

Outcome Measures

Primary Outcomes (1)

• Listening to Music During HSG Affects Women's Pain Level.

  A visual analog scale will be applied to measure patients' pain. A state-continuity scale will be applied to measure their anxiety.Visual Analog Scale (VAS) It was developed to determine the pain levels of sick individuals . It is stated as a reproducible, sensitive and reliable method for assessing pain severity. The individual marks a number from 0 to 10 on a 10-centimeter (cm) vertical or horizontal line. Zero (0) means no pain, and 10 means unbearable pain.State-Trait Anxiety Inventory The items of the scale are arranged in a four-point Likert type and thus the total score is obtained. There are also negative and positive statements in the scale. In order to obtain the total scale score, the sum of the negative items is subtracted from the total of the positive items. The total score of the scale varies between 20 and 80, and a high score means that the individual has a high level of anxiety.

  Up to 7 Months

Secondary Outcomes (1)

• Listening to Music During HSG Affects Women's Anxiety.

  Up to 7 Months

Other Outcomes (4)

• Listening to Music During HSG Effective on Women's Analgesic Use.

  Up to 7 Months

• Natural Landscape Pictures are Effective on the Pain Level of Women during HSG.

  Up to 7 Months

• Natural Landscape Paintings Are Effective On Anxiety Level Of Women During HSG.

  Up to 7 Months

Study Arms (3)

control group

NO INTERVENTION

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.

music group

EXPERIMENTAL

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.

Other: music group

video group

EXPERIMENTAL

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.

Other: video group

Interventions

music group OTHER

music

music group

video group OTHER

video

video group

Eligibility Criteria

• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ŞERİVAN KARAKUT: lead

Study Sites (1)

Şerivan

Gaziantep, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Pain; Charcot-Marie-Tooth Disease, Axonal, Type 2A2

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: lecturer

Model Details: A randomized controlled trial model with pretest-posttest control group

Study Record Dates

• First Submitted: December 30, 2022
• First Posted: February 6, 2023
• Study Start: January 13, 2023
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: February 6, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)