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临床试验/NCT06226337
NCT06226337已完成不适用

The Effect of Music on Pain and Anxiety During Hysterosalpingography: A Randomised Controlled Trial

Ataturk University2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年1月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
2
主要终点
Personal Information Form

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Personal Information Form

时间窗: 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

时间窗: 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)

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ayse Aydin

Dr. Lecturer

Ataturk University

研究点 (2)

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