"The Effect of Inhaler Lavender, Focus and Music on Women's Pain, Anxiety, in Intrauterine Device Application"

Visual Analog Pain Scale Clinical Trial

Official title:

"The Effect of Inhaler Lavender, Focus and Music on Women's Pain, Anxiety, in Intrauterine Device Application"

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06110871
• Other study ID #: TurkishHKahramanmaras
• Status: Recruiting
• Phase: N/A
• Start date: October 19, 2023
• Est. completion date: December 30, 2023

Study information

• Verified date: October 2023
• Source: Turkish Ministry of Health, Kahramanmaras Provincial Health Directorate
• Contact: mine gökduman keles, Midwifery
• Phone: 05055624560
• Email: minegokdumankeles[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Visual Analog Pain Scale

Intervention

Other:
• 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

Locations

Country	Name	City	State
Turkey	TurkishMoHKahramanmarasPH	Kahramanmaras

Sponsors (1)

Lead Sponsor	Collaborator
Turkish Ministry of Health, Kahramanmaras Provincial Health Directorate

Country where clinical trial is conducted

Turkey, 

References & Publications (8)

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. — View 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. — View 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. — View 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. — View 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. Erratum In: J Music Ther. 2021 Aug 24;58(3):372. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Procedure (Speculum insertion)
Primary	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).	up to 10 minutes (During the Pap smear test)
Primary	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).	15 minutes after the Pap smear test.
Primary	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 (	Procedure (Speculum insertion)
Primary	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 (	up to 10 minutes (During the Pap smear test)
Primary	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 (	15 minutes after the Pap smear test.
Primary	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).	5 minutes
Primary	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).	2 minutes

External Links

•   Family planning/contraception methods.
•   TNSA. (2018 ). Türkiye Nüfus ve Saglik Arastirmasi; 2018