Clinical trial NCT06226337: The Effect of Music on Pain and Anxiety During Hysterosalpingography
Official title: The Effect of Music on Pain and Anxiety During Hysterosalpingography: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hysterosalpingography
Keywords: hysterosalpingography
nursing
pain
anxiety
music
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2024-01-26
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Hysterosalpingography Procedure HSG is performed three days a week (Monday, Wednesday, and Thursday) in the Radiology Unit after the decision of the gynecologist. The patient makes an appointment for an HSG examination at the gynecology clinic, based on the last menstrual date. The patient comes to the polyclinic and gives blood to rule out pregnancy on the morning of the HSG scan. At 13:00, she is taken to the Radiology Unit for an HSG scan. The procedure is performed in the lithotomy position. A water-soluble contrast agent (KOPAQ-350 mgl/ml) is injected slowly. Fluoroscopic images are taken intermittently to evaluate the uterus and fallopian tubes. After the HSG procedure, the result is evaluated by the physician.

Nursing Intervention Used in the Study: Music Expert opinion was taken from the Turkish Music Research and Application Center (TUMATA) in determining the music that would be played to the patients. The Maqam that TUMATA recommended for this study was "Acemaşiran Maqam". Acemaşiran Maqam was used in the study because of its pain-relieving and spasm-relieving characteristics and its ability to promote relaxation. The women in the Experimental Group were allowed to listen to music for an average of 15 minutes during the HSG procedure as a nursing intervention. When the patient was laid on the table for the procedure, she was given headphones, and music was played on the MP4 player. HSG lasted approximately 15 minutes. Each patient was given disposable headphones because of hygiene conditions.

Control Group A personal information form was used 10 minutes before the HSG procedure. The patients were asked to fill out the State Anxiety Inventory to determine their anxiety level as a pre-test. Pain was not measured before the procedure because pain develops in women because of the HSG procedure. The women were told that they would be asked to refill the relevant measurement tools for the post-test after the procedure, they were told to write a nickname that would be easy to remember later in the nickname section of the form, and the "Visual Analog Scale" and the "State Anxiety Inventory" were filled in as the post-test 10 minutes after the procedure.

Human Subjects Protection Approval was obtained from Atatürk University Faculty of Medicine Clinical Study Ethics Committee before starting the study (27/01/2022 with the decision number 1/16). Written permission was obtained from the institution where the study was conducted (21/11/2022 with the number 2200382092). The patients were informed about the study and their consent was obtained before starting to collect study data. It was also stated that personal information would not be disclosed to third parties through an "Informed Consent Form" and that care would be taken to comply with the "Principle of Confidentiality and Protection of Confidentiality". The "Anonymity and Security principle" was fulfilled by keeping the data and the identity of the participant confidential. The Principles of the Declaration of Helsinki were followed throughout the study.

Statistical Analysis The data were evaluated in the Statistical Package for the Social Sciences (SPSS) 22 package program. The data were analyzed for normality by using kurtosis and skewness. The threshold for statistical significance was taken as p \< 0.05.

Eligibility 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.

Primary outcomes:
measure: Personal Information Form
timeFrame: 5 months
measure: State Anxiety Inventory
timeFrame: 5 months
measure: Visual Analog Scale (VAS)
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ataturk University Faculty of Nursing
state: Yakuti̇ye
Study officials:
affiliation: Ataturk University Faculty of Nursing
name: Ayşe AYDIN, Dr. Lecturer
role: STUDY_DIRECTOR
References: