HysterosalpingographyNCT05712954
The Effect of Using Music and Natural Landscape Paintings on Pain Level, Anxiety and Analgesic Use of Women During HSG
A study testing music group and video group in people with Hysterosalpingography and Anxiety, run by ŞERİVAN KARAKUT at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hysterosalpingography, Anxiety, Pain
- What is being tested?
- music group and video group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Jan 2023to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Şerivan
Gaziantep
şerivan karakut, 05529422826, srvnkrkt@hotmail.com
ümran sevil, 0554 911 50 26, umransevil@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Hysterosalpingography, Anxiety, Pain
- Being tested
- music group, video group
- Keywords
- hsg, music, natural landscape, anxiety
- Medical subject headings
- Anxiety Disorders, Pain, Charcot-Marie-Tooth Disease, Axonal, Type 2A2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
music groupOther
music
video groupOther
video
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | 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. |
| music group | Experimental | 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. Receives: Other: music group |
| video group | Experimental | 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. Receives: Other: video group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 7 Months
Secondary outcomes (1)
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.
Measured: Up to 7 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start13 Jan 2023
- Primary completion31 Jul 2023 (estimated)
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HysterosalpingographyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized controlled trial model with pretest-posttest control group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ŞERİVAN KARAKUT
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, ŞERİVAN KARAKUT, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05712954
- Sponsor's protocol ID
- 2022/126
- Status last verified
- Jan 2023
- First submitted
- 30 Dec 2022
- Last updated
- 6 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Using Music and Natural Landscape Paintings on Women's Pain Level, Anxiety and Analgesic Use During Hysterosalpingography
- ClinicalTrials.gov ID
- NCT05712954
- Acronym / sponsor ID
- 2022/126
- Conditions
- Hysterosalpingography, Anxiety, Pain
- Keywords
- hsg, music, natural landscape, anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- ŞERİVAN KARAKUTUniversity, hospital or other
- Study start
- 13 Jan 2023 (actual)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 6 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- A randomized controlled trial model with pretest-posttest control group
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –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. |
| music group | Experimental | Other: music groupThe 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. |
| video group | Experimental | Other: video group2. 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| music groupmusic | Other | music group |
| video groupvideo | Other | video group |
Primary outcome
Listening to Music During HSG Affects Women's Pain Level.
Time frame: Up to 7 Months
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.
1 secondary outcome
Listening to Music During HSG Affects Women's Anxiety.
Time frame: Up to 7 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
- Individual participant dataSharing planned: No
Related trials for Hysterosalpingography
Not yet recruitingPhase 4
Pain Control During Hysterosalpingography: A Three-Arm Randomized Trial
Hysterosalpingography-Related Pain
RecruitingEarly Phase 1
The Hysterosalpingogram (HSG) Experience And Tubal Spasm (HEAT) Study
Infertility
Not yet recruiting
Effect of Music in Reducing Pain and Anxiety During Hysterosalpingography in Women With Primary Infertility
Pain
Not yet recruitingPhase 3
Lidocaine Prilocaine Spray in Reducing Pain During Hysterosalpingography in Women With Primary Infertility
Infertility, Female
Active, not recruitingObservational study
Comparison of Ultrasound and Hysterosalpingography in Evaluation of Uterine Abnormality in Patients With Infertility
Uterine Abnormality
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing music group and video group in people with Hysterosalpingography and Anxiety, run by ŞERİVAN KARAKUT at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Listening to Music During HSG Affects Women's Pain Level. (time frame: Up to 7 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2023.