NCT06226337

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 22, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 4, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 4, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 4, 2024

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 26, 2024

Completed
Last Updated

January 26, 2024

Status Verified

January 1, 2024

Enrollment Period

1.7 years

First QC Date

January 4, 2024

Last Update Submit

January 25, 2024

Conditions

Hysterosalpingography

Keywords

hysterosalpingographynursingpainanxietymusic

Outcome Measures

Primary Outcomes (3)

  • Personal Information Form

    Personal Information Form:The form, which was prepared by the researcher in line with the literature data, included 10 questions

    5 months

  • State Anxiety Inventory

    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.

    5 months

  • Visual Analog Scale (VAS)

    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.

    5 months

Study Arms (2)

No intervention: control group

NO INTERVENTION

No intervention was applied to the control group other than routine practice.45 women were assigned to the control group

Experimental group

EXPERIMENTAL

45 women to the experimental group. In the study, the experimental group Acemaşiran makam was played to the women as music during hysterosalpingography.

Other: listen music

Interventions

listen musicOTHER

During hysterosalpingography, women were listened to the Acemaşiran maqam as music via MP4 players and headphones.

Experimental group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsHave Hsg done
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk University Faculty of Nursing

Erzurum, Yakuti̇ye, 25240, Turkey (Türkiye)

Location

MeSH Terms

Conditions

PainAnxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Ayşe AYDIN, Dr. Lecturer

    Ataturk University Faculty of Nursing

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Lecturer

Study Record Dates

First Submitted

January 4, 2024

First Posted

January 26, 2024

Study Start

January 22, 2022

Primary Completion

October 4, 2023

Study Completion

December 4, 2023

Last Updated

January 26, 2024

Record last verified: 2024-01

Locations

TU(1)