Visual Analog Pain ScaleNCT06110871
"The Effect of Inhaler Lavender, Focus and Music on Women's Pain, Anxiety, in Intrauterine Device Application"
A study testing inhaled lavender, Working Group 2: Focusing and Working Group 3 music in people with Visual Analog Pain Scale, run by Turkish Ministry of Health, Kahramanmaras Provincial Health Directorate at 1 site in Turkey (Türkiye).
Trial summary
Randomized control is an experimental study. The purpose of this research; To examine the effects of inhaler lavender, focus and music on women's pain and anxi.ety in intrauterine device application. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Visual Analog Pain Scale
- What is being tested?
- inhaled lavender, Working Group 2: Focusing and Working Group 3 music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Oct 2023to 30 Dec 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
- Being between the ages of 18-45,
- having IUD applied for the first time,
- being literate in Turkish,
- having no history of cervical surgery,
- having no active mental illness,
- having no pain before IUD application.
Who cannot join
- Having communication problems,
- visual or auditory disabilities,
- use of misoprostol during the procedure,
- use of painkillers before the IUD application procedure,
- use of medication for anxiety before the procedure.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
TurkishMoHKahramanmarasPH
Kahramanmaraş, 46050
mine KELEŞ, 5055624560, minegkdmn@hotmail.com
About this study
Randomized control is an experimental study. The purpose of this research; To examine the effects of inhaler lavender, focus and music on women's pain and anxi.ety in intrauterine device application.
In the randomized controlled experimental study, data would be obtained using the Numerical Anxiety Rating Scale and the Numerical Pain Rating Scale. 240 women who underwent IUD procedure at the Family Planning Consultancy Polyclinic of a secondary level public hospital in a city center between October and December 2023 were randomly assigned to receive 4 sets of 1 set of Inhaled lavender (60), 1 set of Focusing (60), 1 set of Music ( 60). 1 control group (60) will participate in the study.
Read the detailed description
The rate of women who want to use Family Planning in the world has reached approximately 1.1 billion in the last twenty years and has shown a significant increase ( WHO, 2020) . In addition, WHO reported that almost half of the pregnancies in developing countries between 2015 and 2019 were unwanted pregnancies (WHO, 2020) , and recommended effective FP counseling and the use of more modern contraceptive methods to prevent this (WHO, 2020) . In Turkey, the Ministry of Health provides individuals with free access to modern FP methods. Despite this, according to the 2018 data of the Turkey Demographic and Health Survey ( Akdemir and Karadeniz 2019), it has been reported that 49% of the FP method uses modern methods and the Intrauterine Device (IUD) is among the most effective modern methods with a rate of 14% (Akdemir and Karadeniz 2019 ). Factors affecting IUD use include; Women's perception of pain during application and the fact that it can be applied in certain centers (Dine et al,2018; Hunter et al, 2020; Hamdamian et al., 2018).
It has been reported in the literature that women perceive pain during IUD application (Akdemir and Karadeniz 2019; Dine et al,2018; Hunter et al, 2020; Hamdamian et al., 2018). Again, studies have reported the use of inhaled lavender, focus, and music to relieve pain and anxiety (Hamdamian et al., 2018; Hathcock et al., 2021; Türkmen et al.,2021) . These results emphasize the need for low-cost and applicable nonpharmacological methods for healthcare professionals during IUD insertion.
No study has been found in the literature examining the effects of inhaler lavender, focus and music on women's pain and anxiety during intrauterine device application. However, in line with the results of the study, it is thought that it will have a positive effect on reducing the pain and anxiety perceived by women during the IUD procedure.
- Conditions
- Visual Analog Pain Scale
- Being tested
- inhaled lavender, Working Group 2: Focusing, Working Group 3 music
- Keywords
- Virtual Reality, Inhaler Lavende, Pain, Anxiety, Intrauterine Device Application
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inhaled lavenderOther
They will be asked to inhale deeply 10 times. Then, a total of 30 minutes in the waiting room where aromastone is located and in the IA application room.
Working Group 2: FocusingOther
During IUD application
Working Group 3 musicOther
Also called music
for a total of 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| Working Group 1(inhaled lavender) | Experimental | In study group 1, 3 drops of lavender oil will be dropped on aromastone and participants will be asked to inhale deeply 10 times. Then, participants will be allowed to inhale lavender oil for a total of 30 minutes in the waiting room where aromastone is located and in the ria application room. Receives: Other: inhaled lavender |
| Working Group 2: Focusing | Experimental | After the internet connection is established with the smartphone, you can click on www.youtube.com and watch the "Relaxation Project 1" (SBS VR) video for the image and ask to focus. Receives: Other: Working Group 2: Focusing |
| Working Group 3 music | Experimental | You will be able to listen to Turkish classical music for a total of 30 minutes in the RIA application waiting room and RIA application room. Receives: Other: Working Group 3 music |
| Control Group | No intervention | The care and practices will be the same as in routine IUD application. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Pain Rating Scale Pain
Numerical Pain Assessment Scale Pain (NADÖ): Numerical Pain Assessment Scale (NADÖ) is used to evaluate the severity of pain. On the numerical rating scale, pain ranges from 0 (absence of pain) to 10 (unbearable pain).
Measured: Procedure (Speculum insertion)
Numerical Pain Rating Scale Pain
Numerical Pain Assessment Scale Pain (NADÖ): Numerical Pain Assessment Scale (NADÖ) is used to evaluate the severity of pain. On the numerical rating scale, pain ranges from 0 (absence of pain) to 10 (unbearable pain).
Measured: up to 10 minutes (During the Pap smear test)
Numerical Pain Rating Scale Pain
Numerical Pain Assessment Scale Pain (NADÖ): Numerical Pain Assessment Scale (NADÖ) is used to evaluate the severity of pain. On the numerical rating scale, pain ranges from 0 (absence of pain) to 10 (unbearable pain).
Measured: 15 minutes after the Pap smear test.
The Verbal Category Scale
The Verbal Category Scale is also called the Simple Descriptive Scale, and this scale is based on the patient choosing the most appropriate word that describes the pain condition. Pain intensity ranges from mild to unbearable. In this scale, the words "mild", "disturbing", "severe", "very severe", "unbearable" were used to describe the intensity of pain (
Measured: Procedure (Speculum insertion)
The Verbal Category Scale
The Verbal Category Scale is also called the Simple Descriptive Scale, and this scale is based on the patient choosing the most appropriate word that describes the pain condition. Pain intensity ranges from mild to unbearable. In this scale, the words "mild", "disturbing", "severe", "very severe", "unbearable" were used to describe the intensity of pain (
Measured: up to 10 minutes (During the Pap smear test)
The Verbal Category Scale
The Verbal Category Scale is also called the Simple Descriptive Scale, and this scale is based on the patient choosing the most appropriate word that describes the pain condition. Pain intensity ranges from mild to unbearable. In this scale, the words "mild", "disturbing", "severe", "very severe", "unbearable" were used to describe the intensity of pain (
Measured: 15 minutes after the Pap smear test.
Numerical Rating Scale for Anxiety (VASA).
Numerical Rating Scale for Anxiety (VASA). It is expressed as whether the individual feels anxiety (e.g., I have a lot of anxiety = 10) or does not feel anxiety (e.g., I have no anxiety = 0).
Measured: 5 minutes
Numerical Rating Scale for Anxiety (VASA).
Numerical Rating Scale for Anxiety (VASA). It is expressed a Outcome 8s whether the individual feels anxiety (e.g., I have a lot of anxiety = 10) or does not feel anxiety (e.g., I have no anxiety = 0).
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start19 Oct 2023
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Visual Analog Pain ScaleStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- In our research, there will be 3 interventions (Group 1 is a focus group, Group 2 is the Group where inhaled kavanta is used, Group 3 will be listened to music) and 1 control group (The group where IIA is applied and receives routine care). .
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turkish Ministry of Health, Kahramanmaras Provincial Health Directorate
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mine Gokduman Keles, Turkish Ministry of Health, Kahramanmaras Provincial Health Directorate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06110871
- Sponsor's protocol ID
- TurkishHKahramanmaras
- Status last verified
- Oct 2023
- First submitted
- 20 Oct 2023
- Last updated
- 1 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Akdemir Y, Karadeniz M. The relationship between pain at IUD insertion and negative perceptions, anxiety and previous mode of delivery. Eur J Contracept Reprod Health Care. 2019 Jun;24(3):240-245. doi: 10.1080/13625187.2019.1610872. Epub 2019 May 16.
PubMed 31094575Dina B, Peipert LJ, Zhao Q, Peipert JF. Anticipated pain as a predictor of discomfort with intrauterine device placement. Am J Obstet Gynecol. 2018 Feb;218(2):236.e1-236.e9. doi: 10.1016/j.ajog.2017.10.017. Epub 2017 Nov 8.
PubMed 29079143Hunter TA, Sonalkar S, Schreiber CA, Perriera LK, Sammel MD, Akers AY. Anticipated Pain During Intrauterine Device Insertion. J Pediatr Adolesc Gynecol. 2020 Feb;33(1):27-32. doi: 10.1016/j.jpag.2019.09.007. Epub 2019 Sep 26.
PubMed 31563628Hamdamian S, Nazarpour S, Simbar M, Hajian S, Mojab F, Talebi A. Effects of aromatherapy with Rosa damascena on nulliparous women's pain and anxiety of labor during first stage of labor. J Integr Med. 2018 Mar;16(2):120-125. doi: 10.1016/j.joim.2018.02.005. Epub 2018 Feb 9.
PubMed 29526235Wojcik A, Bonk K, Muller WU, Obe G, Streffer C. Do DNA double-strand breaks induced by Alu I lead to development of novel aberrations in the second and third post-treatment mitoses? Radiat Res. 1996 Feb;145(2):119-27.
PubMed 8606920Turkmen H, Cetinkaya S, Kilic H, Apay E, Karamuftuoglu D, Yoruk S, Ozkirim E. Effect of Focusing on Maryam's Flower During the First Stage of the Labor on the Labor Pain, Labor Duration, and Levels of Comfort and Satisfaction. Clin Nurs Res. 2021 Jul;30(6):780-789. doi: 10.1177/1054773820984911. Epub 2020 Dec 29.
PubMed 33371726Lee JH. The Effects of Music on Pain: A Meta-Analysis. J Music Ther. 2016 Winter;53(4):430-477. doi: 10.1093/jmt/thw012. Epub 2016 Oct 19.
PubMed 27760797Toker E, Demirel G, Doganer A, Karakucuk S. Effects of Turkish Classical Music on Postpartum Pain and Anxiety in Cesarean Deliveries: A Randomized Controlled Trial. Altern Ther Health Med. 2021 Jun;27(S1):120-127.
PubMed 33245708
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "The Effect of Inhaler Lavender, Focus and Music on Women's Pain, Anxiety, in Intrauterine Device Application"
- ClinicalTrials.gov ID
- NCT06110871
- Acronym / sponsor ID
- TurkishHKahramanmaras
- Conditions
- Visual Analog Pain Scale
- Keywords
- Virtual Reality, Inhaler Lavende, Pain, Anxiety, Intrauterine Device Application
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Turkish Ministry of Health, Kahramanmaras Provincial Health DirectorateOther government
- Study start
- 19 Oct 2023 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 1 Nov 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.
Randomized control is an experimental study. The purpose of this research; To examine the effects of inhaler lavender, focus and music on women's pain and anxi.ety in intrauterine device application.
In the randomized controlled experimental study, data would be obtained using the Numerical Anxiety Rating Scale and the Numerical Pain Rating Scale. 240 women who underwent IUD procedure at the Family Planning Consultancy Polyclinic of a secondary level public hospital in a city center between October and December 2023 were randomly assigned to receive 4 sets of 1 set of Inhaled lavender (60), 1 set of Focusing (60), 1 set of Music ( 60). 1 control group (60) will participate in the study.
Detailed description
The rate of women who want to use Family Planning in the world has reached approximately 1.1 billion in the last twenty years and has shown a significant increase ( WHO, 2020) . In addition, WHO reported that almost half of the pregnancies in developing countries between 2015 and 2019 were unwanted pregnancies (WHO, 2020) , and recommended effective FP counseling and the use of more modern contraceptive methods to prevent this (WHO, 2020) . In Turkey, the Ministry of Health provides individuals with free access to modern FP methods. Despite this, according to the 2018 data of the Turkey Demographic and Health Survey ( Akdemir and Karadeniz 2019), it has been reported that 49% of the FP method uses modern methods and the Intrauterine Device (IUD) is among the most effective modern methods with a rate of 14% (Akdemir and Karadeniz 2019 ). Factors affecting IUD use include; Women's perception of pain during application and the fact that it can be applied in certain centers (Dine et al,2018; Hunter et al, 2020; Hamdamian et al., 2018).
It has been reported in the literature that women perceive pain during IUD application (Akdemir and Karadeniz 2019; Dine et al,2018; Hunter et al, 2020; Hamdamian et al., 2018). Again, studies have reported the use of inhaled lavender, focus, and music to relieve pain and anxiety (Hamdamian et al., 2018; Hathcock et al., 2021; Türkmen et al.,2021) . These results emphasize the need for low-cost and applicable nonpharmacological methods for healthcare professionals during IUD insertion.
No study has been found in the literature examining the effects of inhaler lavender, focus and music on women's pain and anxiety during intrauterine device application. However, in line with the results of the study, it is thought that it will have a positive effect on reducing the pain and anxiety perceived by women during the IUD procedure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- In our research, there will be 3 interventions (Group 1 is a focus group, Group 2 is the Group where inhaled kavanta is used, Group 3 will be listened to music) and 1 control group (The group where IIA is applied and receives routine care). .
| Arm | Type | Receives |
|---|---|---|
| Working Group 1(inhaled lavender) | Experimental | Other: inhaled lavenderIn study group 1, 3 drops of lavender oil will be dropped on aromastone and participants will be asked to inhale deeply 10 times. Then, participants will be allowed to inhale lavender oil for a total of 30 minutes in the waiting room where aromastone is located and in the ria application room. |
| Working Group 2: Focusing | Experimental | Other: Working Group 2: FocusingAfter the internet connection is established with the smartphone, you can click on www.youtube.com and watch the "Relaxation Project 1" (SBS VR) video for the image and ask to focus. |
| Working Group 3 music | Experimental | Other: Working Group 3 musicYou will be able to listen to Turkish classical music for a total of 30 minutes in the RIA application waiting room and RIA application room. |
| Control Group | No intervention | –The care and practices will be the same as in routine IUD application. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Being between the ages of 18-45,
- having IUD applied for the first time,
- being literate in Turkish,
- having no history of cervical surgery,
- having no active mental illness,
Key exclusion criteria (5 listed)
- Having communication problems,
- visual or auditory disabilities,
- use of misoprostol during the procedure,
- use of painkillers before the IUD application procedure,
- use of medication for anxiety before the procedure.
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 |
|---|---|---|
| inhaled lavenderThey will be asked to inhale deeply 10 times. Then, a total of 30 minutes in the waiting room where aromastone is located and in the IA application room. | Other | Working Group 1(inhaled lavender) |
| Working Group 2: FocusingDuring IUD application | Other | Working Group 2: Focusing |
| Working Group 3 musicAlso: musicfor a total of 30 minutes | Other | Working Group 3 music |
Primary outcome
Numerical Pain Rating Scale Pain
Time frame: Procedure (Speculum insertion)
Numerical Pain Assessment Scale Pain (NADÖ): Numerical Pain Assessment Scale (NADÖ) is used to evaluate the severity of pain. On the numerical rating scale, pain ranges from 0 (absence of pain) to 10 (unbearable pain).
Numerical Pain Rating Scale Pain
Time frame: up to 10 minutes (During the Pap smear test)
Numerical Pain Assessment Scale Pain (NADÖ): Numerical Pain Assessment Scale (NADÖ) is used to evaluate the severity of pain. On the numerical rating scale, pain ranges from 0 (absence of pain) to 10 (unbearable pain).
Numerical Pain Rating Scale Pain
Time frame: 15 minutes after the Pap smear test.
Numerical Pain Assessment Scale Pain (NADÖ): Numerical Pain Assessment Scale (NADÖ) is used to evaluate the severity of pain. On the numerical rating scale, pain ranges from 0 (absence of pain) to 10 (unbearable pain).
The Verbal Category Scale
Time frame: Procedure (Speculum insertion)
The Verbal Category Scale is also called the Simple Descriptive Scale, and this scale is based on the patient choosing the most appropriate word that describes the pain condition. Pain intensity ranges from mild to unbearable. In this scale, the words "mild", "disturbing", "severe", "very severe", "unbearable" were used to describe the intensity of pain (
The Verbal Category Scale
Time frame: up to 10 minutes (During the Pap smear test)
The Verbal Category Scale is also called the Simple Descriptive Scale, and this scale is based on the patient choosing the most appropriate word that describes the pain condition. Pain intensity ranges from mild to unbearable. In this scale, the words "mild", "disturbing", "severe", "very severe", "unbearable" were used to describe the intensity of pain (
The Verbal Category Scale
Time frame: 15 minutes after the Pap smear test.
The Verbal Category Scale is also called the Simple Descriptive Scale, and this scale is based on the patient choosing the most appropriate word that describes the pain condition. Pain intensity ranges from mild to unbearable. In this scale, the words "mild", "disturbing", "severe", "very severe", "unbearable" were used to describe the intensity of pain (
Numerical Rating Scale for Anxiety (VASA).
Time frame: 5 minutes
Numerical Rating Scale for Anxiety (VASA). It is expressed as whether the individual feels anxiety (e.g., I have a lot of anxiety = 10) or does not feel anxiety (e.g., I have no anxiety = 0).
Numerical Rating Scale for Anxiety (VASA).
Time frame: 2 minutes
Numerical Rating Scale for Anxiety (VASA). It is expressed a Outcome 8s whether the individual feels anxiety (e.g., I have a lot of anxiety = 10) or does not feel anxiety (e.g., I have no anxiety = 0).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
- Background: PubMed 31094575Akdemir Y, Karadeniz M. The relationship between pain at IUD insertion and negative perceptions, anxiety and previous mode of delivery. Eur J Contracept Reprod Health Care. 2019 Jun;24(3):240-245. doi: 10.1080/13625187.2019.1610872. Epub 2019 May 16.
- Background: PubMed 29079143Dina B, Peipert LJ, Zhao Q, Peipert JF. Anticipated pain as a predictor of discomfort with intrauterine device placement. Am J Obstet Gynecol. 2018 Feb;218(2):236.e1-236.e9. doi: 10.1016/j.ajog.2017.10.017. Epub 2017 Nov 8.
- Background: PubMed 31563628Hunter TA, Sonalkar S, Schreiber CA, Perriera LK, Sammel MD, Akers AY. Anticipated Pain During Intrauterine Device Insertion. J Pediatr Adolesc Gynecol. 2020 Feb;33(1):27-32. doi: 10.1016/j.jpag.2019.09.007. Epub 2019 Sep 26.
- Background: PubMed 29526235Hamdamian S, Nazarpour S, Simbar M, Hajian S, Mojab F, Talebi A. Effects of aromatherapy with Rosa damascena on nulliparous women's pain and anxiety of labor during first stage of labor. J Integr Med. 2018 Mar;16(2):120-125. doi: 10.1016/j.joim.2018.02.005. Epub 2018 Feb 9.
- Background: PubMed 8606920Wojcik A, Bonk K, Muller WU, Obe G, Streffer C. Do DNA double-strand breaks induced by Alu I lead to development of novel aberrations in the second and third post-treatment mitoses? Radiat Res. 1996 Feb;145(2):119-27.
- Background: PubMed 33371726Turkmen H, Cetinkaya S, Kilic H, Apay E, Karamuftuoglu D, Yoruk S, Ozkirim E. Effect of Focusing on Maryam's Flower During the First Stage of the Labor on the Labor Pain, Labor Duration, and Levels of Comfort and Satisfaction. Clin Nurs Res. 2021 Jul;30(6):780-789. doi: 10.1177/1054773820984911. Epub 2020 Dec 29.
- Background: PubMed 27760797Lee JH. The Effects of Music on Pain: A Meta-Analysis. J Music Ther. 2016 Winter;53(4):430-477. doi: 10.1093/jmt/thw012. Epub 2016 Oct 19.
- Background: PubMed 33245708Toker E, Demirel G, Doganer A, Karakucuk S. Effects of Turkish Classical Music on Postpartum Pain and Anxiety in Cesarean Deliveries: A Randomized Controlled Trial. Altern Ther Health Med. 2021 Jun;27(S1):120-127.
- Family planning/contraception methods.Link provided by the sponsor.
- TNSA. (2018 ). Türkiye Nüfus ve Sağlık Araştırması; 2018Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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 inhaled lavender, Working Group 2: Focusing and Working Group 3 music in people with Visual Analog Pain Scale, run by Turkish Ministry of Health, Kahramanmaras Provincial Health Directorate 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 6 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 1 Nov 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?
Contact mine gökduman keleş, Midwifery (05055624560 ext. 0, minegokdumankeles@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Pain Rating Scale Pain (time frame: Procedure (Speculum insertion)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06110871, which also lists 8 linked publications.
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 1 Nov 2023.