"The Effect of Inhaler Lavender, Focus and Music on Women's Pain, Anxiety, in Intrauterine Device Application"
NCT ID: NCT06110871
Last Updated: 2023-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
240 participants
INTERVENTIONAL
2023-10-19
2023-12-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of Music on Anxiety Levels During Intrauterine Device Application
NCT07038187
The Effect of Two Non-pharmacological Methods on Pain and Anxiety Experienced During Intrauterine Device Application.
NCT06277726
Stress Balls in Gynecologic Exams: A Patient Comfort Trial
NCT06679231
The Effect of Using a Stress Ball During Vaginal Examination on Anxiety and Pain Levels: a Randomized Controlled Study
NCT06263166
Effect of Multi-Sensory Interventions on Labor Pain, Comfort, and Birth Satisfaction
NCT07248787
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SEQUENTIAL
SUPPORTIVE_CARE
TRIPLE
THE RESEARCHER WILL HAVE NO INTERVENTION DURING IUD APPLICATION.
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Working Group 1(inhaled lavender)
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.
inhaled lavender
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: Focusing
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.
Working Group 2: Focusing
During IUD application
Working Group 3 music
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.
Working Group 3 music
for a total of 30 minutes
Control Group
The care and practices will be the same as in routine IUD application.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
inhaled lavender
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: Focusing
During IUD application
Working Group 3 music
for a total of 30 minutes
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Turkish Ministry of Health, Kahramanmaras Provincial Health Directorate
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Mine Gokduman Keles
Midwifery
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
TurkishMoHKahramanmarasPH
Kahramanmaraş, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Dina 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.
Hunter 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.
Hamdamian 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.
Wojcik 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.
Turkmen 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.
Lee 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.
Toker 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.
Related Links
Access external resources that provide additional context or updates about the study.
Family planning/contraception methods.
TNSA. (2018 ). Türkiye Nüfus ve Sağlık Araştırması; 2018
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TurkishHKahramanmaras
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.