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

October 31, 2023 updated by: Mine Gokduman Keles, Turkish Ministry of Health, Kahramanmaras Provincial Health Directorate

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
      • Kahramanmaraş, Turkey, 46050
        • Recruiting
        • TurkishMoHKahramanmarasPH
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Experimental: 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.
Other: Working Group 2: Focusing
During IUD application
Experimental: 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.
Other: Working Group 3 music
for a total of 30 minutes
Other Names:
  • music
No Intervention: Control Group
The care and practices will be the same as in routine IUD application.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Procedure (Speculum insertion)
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).
up to 10 minutes (During the Pap smear test)
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).
15 minutes after the Pap smear test.
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 (
Procedure (Speculum insertion)
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 (
up to 10 minutes (During the Pap smear test)
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 (
15 minutes after the Pap smear test.
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).
5 minutes
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).
2 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Turkish Ministry of Health, Kahramanmaras Provincial Health Directorate

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 19, 2023

Primary Completion (Estimated)

December 30, 2023

Study Completion (Estimated)

December 30, 2023

Study Registration Dates

First Submitted

October 20, 2023

First Submitted That Met QC Criteria

October 31, 2023

First Posted (Actual)

November 1, 2023

Study Record Updates

Last Update Posted (Actual)

November 1, 2023

Last Update Submitted That Met QC Criteria

October 31, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TurkishHKahramanmaras

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Visual Analog Pain Scale

Clinical Trials on inhaled lavender

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Nigeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe