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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pain; Anxiety; Hysterosalpingography
• Intervention / Treatment: Other: music group; Other: video group

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Gaziantep, Turkey
    • Recruiting
    • Şerivan
    • Contact: şerivan karakut; Phone Number: 05529422826; Email: srvnkrkt@hotmail.com
    • Contact: ümran sevil; Phone Number: 0554 911 50 26; Email: umransevil@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: 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.
EXPERIMENTAL: 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.	Other: music group; music
EXPERIMENTAL: 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.	Other: video group; video

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Listening to Music During HSG Affects Women's Anxiety.	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Listening to Music During HSG Effective on Women's Analgesic Use.	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
Natural Landscape Pictures are Effective on the Pain Level of Women during HSG.	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
Natural Landscape Paintings Are Effective On Anxiety Level Of Women During HSG.	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
Natural Landscape Paintings During HSG Are Effective in Women's Use of Analgesics.	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

Collaborators and Investigators

• Sponsor: ŞERİVAN KARAKUT

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 13, 2023
• Primary Completion (ANTICIPATED): July 31, 2023
• Study Completion (ANTICIPATED): July 31, 2023

Study Registration Dates

• First Submitted: December 30, 2022
• First Submitted That Met QC Criteria: January 26, 2023
• First Posted (ACTUAL): February 6, 2023

Study Record Updates

• Last Update Posted (ACTUAL): February 6, 2023
• Last Update Submitted That Met QC Criteria: January 26, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: anxiety; music; hsg; natural landscape
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 2022/126

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No