The Effect of Music on Pain and Anxiety During Hysterosalpingography: A Randomised Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ataturk University
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Personal Information Form
Study Overview
Brief Summary
This randomised controlled experimental study was conducted at the Gynecology Polyclinic of Atatürk University Health Research and Application Center between 27.01. 2022 and 04.12.2023. Population of the study consisted of women admitted to the relevant institution for hysterosalpingography.
Sample of the study consisted of a total of 80 women, 40 in the experimental group and 40 in the control group, who met the research criteria from the specified population. In the study, the women in the experimental group were listened to Acemaşiran makam as music during hysterosalpingography. No intervention was applied to the control group except routine practice. "Personal Information Form", "Visual Analogue Scale (VAS)" and "State Anxiety Scale" were used to collect the data.
Detailed Description
Hysterosalpingography (HSG) is a diagnostic radiological procedure used widely to investigate infertility as an invasive, uncomfortable, and painful procedure. The purpose of the present study was to examine the effects of music played to women during Hysterosalpingography on pain and anxiety.
Study design: The study had a randomized-controlled double-blind design. Setting and Sample: The population of the study consisted of women who applied to the Gynecology outpatient clinic of Atatürk University Health Study and Application Center between 01.06.2023 and 01.11.2023 to undergo Hysterosalpingography. HSG scans are performed in the Radiology Unit of the hospital. The sample number of the study was calculated by using the G*Power Program (version 3.1.9.6). The number of samples for each group was calculated as 35 in the calculation, with a large effect size (d = 0.80), 5% margin of error (α = 0.05), and 95% power (1-β = 0.80). Considering the possibility of data losses, the number of samples was increased by 10 for each group and it was planned to include 45 participants in each group (a total of 90 people in the sample). A total of 45 women were assigned to the Experimental Group and 45 women to the Control Group with the Simple Randomization Technique. Five people from the Control Group (they did not fill out the post-test data collection tool) and five people from the Experimental Group (three people left at their own request, and two people were excluded because they used analgesics) were excluded from the study during the study period. The study was completed with 80 women (40 in the Experimental Group and 40 in the Control Group).
Inclusion and Exclusion Criteria Inclusion criteria Being over 18 years of age, being at least a primary school graduate, agreeing to participate in the study voluntarily, having no active infections, no vaginal bleeding on the day of the procedure, not having had an HSG before, not receiving sedation, not having a hearing problem, and not having any obstacle to wearing headphones (for the Experimental Group), not taking any medications that might affect blood pressure and pulse rate (e.g., Digoxin, Adrenaline), and not having a diagnosed psychiatric disease.
Exclusion Criteria Using analgesics before or after the procedure, using antidepressants or sedative medications, being allergic to radio-opaque material, not completing the procedure, not completing one of the pre-test or post-test forms, filling in incomplete data, and leaving the study voluntarily.
Data Collection and Procedure Data Collection The data of the study were collected with the face-to-face interview technique between 01.06.2023 and 01.11.2023 by a neutral researcher (a nurse) who was not familiar with the groups trained by the researcher. The women participating in the study were interviewed at the clinic where they applied for the procedure, the purpose and stages of the study were explained, and they were told that they could withdraw at any stage of the study. Before starting to collect the study data, women were informed about the study, and their consent was obtained. It took an average of 5-10 minutes for each patient to fill out the forms.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Being over 18 years of age, being at least a primary school graduate, agreeing to participate in the study voluntarily, having no active infections, no vaginal bleeding on the day of the procedure, not having had an HSG before, not receiving sedation, not having a hearing problem, and not having any obstacle to wearing headphones (for the Experimental Group), not taking any medications that might affect blood pressure and pulse rate (e.g., Digoxin, Adrenaline), and not having a diagnosed psychiatric disease.
Exclusion Criteria
- •Using analgesics before or after the procedure, using antidepressants or sedative medications, being allergic to radio-opaque material, not completing the procedure, not completing one of the pre-test or post-test forms, filling in incomplete data, and leaving the study voluntarily.
Arms & Interventions
No intervention: control group
No intervention was applied to the control group other than routine practice.45 women were assigned to the control group
Experimental group
45 women to the experimental group. In the study, the experimental group Acemaşiran makam was played to the women as music during hysterosalpingography.
Intervention: listen music (Other)
Outcomes
Primary Outcomes
Personal Information Form
Time Frame: 5 months
Personal Information Form:The form, which was prepared by the researcher in line with the literature data, included 10 questions
State Anxiety Inventory
Time Frame: 5 months
There are 20 questions in the state part of the scale providing a four-point Likert-type measurement. On the scale, the scoring varies between 1 (not at all) and 4 (completely). One point indicates that the situation stated in the question does not reflect the individual at all, and 4 points indicate that the situation reflects the individual completely. The highest score is 80 and the lowest score is 20. A high total score indicates that the individual's anxiety level is also high.The scores between 20 and 37 indicate no or minimal anxiety, scores between 38 and 44 indicate moderate anxiety, and scores between 45 and 80 indicate high anxiety on the State Anxiety Inventory.
Visual Analog Scale (VAS)
Time Frame: 5 months
Visual Analog Scale is an evaluation tool in which patients mark on a 10 cm ruler. The 10 cm scale, which is a numerical pain assessment scale, starts with "No pain (0)" and ends with "Unbearable pain (10)". The patient is asked to mark the place that expresses his/her pain on the line. The distance marked by the patient is measured by taking the zero starting distance. The pain level of the patient is determined in this way. The horizontally prepared VAS was used to evaluate pain intensity in this study. The reason for choosing this scale in the study was that it is easily understandable by the participants and easy to use.
Secondary Outcomes
No secondary outcomes reported
Investigators
Ayse Aydin
Dr. Lecturer
Ataturk University