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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06110871
Enrollment
240
Registered
2023-11-01
Start date
2023-10-19
Completion date
2023-12-30
Last updated
2023-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Visual Analog Pain Scale

Keywords

Virtual Reality, Inhaler Lavende, Pain, Anxiety, Intrauterine Device Application

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.

Interventions

OTHERinhaled 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.

OTHERWorking Group 2: Focusing

During IUD application

OTHERWorking Group 3 music

for a total of 30 minutes

Sponsors

Turkish Ministry of Health, Kahramanmaras Provincial Health Directorate
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Masking description

PERSON USING IUD. IT WILL ALWAYS BE THE SAME AND THERE WILL BE ONE PERSON WHO HAS NOTHING TO DO WITH THE RESEARCH. THE RESEARCHER WILL HAVE NO INTERVENTION DURING IUD APPLICATION.

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). .

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Numerical Pain Rating Scale PainProcedure (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).
The Verbal Category ScaleProcedure (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 (
Numerical Rating Scale for Anxiety (VASA).5 minutesNumerical 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).

Countries

Turkey (Türkiye)

Contacts

Primary Contactmine gökduman keleş, Midwifery
minegokdumankeles@gmail.com05055624560
Backup Contactmine gökduman keleş, PhD.
minegokdumankeles@gmail.com05055624560

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026