Clinical trial NCT06110871: "The Effect of Inhaler Lavender, Focus and Music on Women's Pain, Anxiety, in Intrauterine Device Application"
Official title: "The Effect of Inhaler Lavender, Focus and Music on Women's Pain, Anxiety, in Intrauterine Device Application"
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Visual Analog Pain Scale
Keywords: Virtual Reality
Inhaler Lavende
Pain
Anxiety
Intrauterine Device Application
Lead sponsor: Turkish Ministry of Health, Kahramanmaras Provincial Health Directorate
Sponsor class: OTHER_GOV
First posted: 2023-11-01
Enrollment: 240
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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). .
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Numerical Pain Rating Scale Pain
timeFrame: Procedure (Speculum insertion)
measure: Numerical Pain Rating Scale Pain
timeFrame: up to 10 minutes (During the Pap smear test)
measure: Numerical Pain Rating Scale Pain
timeFrame: 15 minutes after the Pap smear test.
measure: The Verbal Category Scale
timeFrame: Procedure (Speculum insertion)
measure: The Verbal Category Scale
timeFrame: up to 10 minutes (During the Pap smear test)
measure: The Verbal Category Scale
timeFrame: 15 minutes after the Pap smear test.
measure: Numerical Rating Scale for Anxiety (VASA).
timeFrame: 5 minutes
measure: Numerical Rating Scale for Anxiety (VASA).
timeFrame: 2 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Kahramanmaraş
country: Turkey
facility: TurkishMoHKahramanmarasPH
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.