NCT06110871

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 19, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 20, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

November 1, 2023

Status Verified

October 1, 2023

Enrollment Period

2 months

First QC Date

October 20, 2023

Last Update Submit

October 31, 2023

Conditions

Visual Analog Pain Scale

Keywords

Virtual RealityInhaler LavendePainAnxietyIntrauterine Device Application

Outcome Measures

Primary Outcomes (8)

  • 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)

  • 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)

  • 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.

  • 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)

  • 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)

  • 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.

  • 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

  • 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

Study Arms (4)

Working Group 1(inhaled lavender)

EXPERIMENTAL

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

Working Group 2: Focusing

EXPERIMENTAL

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

Working Group 3 music

EXPERIMENTAL

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

Control Group

NO INTERVENTION

The care and practices will be the same as in routine IUD application.

Interventions

inhaled lavenderOTHER

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 1(inhaled lavender)
Working Group 2: FocusingOTHER

During IUD application

Working Group 2: Focusing
Working Group 3 musicOTHER

for a total of 30 minutes

Also known as: music
Working Group 3 music

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsIntrauterine Device Application women
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TurkishMoHKahramanmarasPH

Kahramanmaraş, 46050, Turkey (Türkiye)

RECRUITING

Related 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.

    PMID: 31094575BACKGROUND

  • 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.

    PMID: 29079143BACKGROUND

  • 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.

    PMID: 31563628BACKGROUND

  • 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.

    PMID: 29526235BACKGROUND

  • 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.

    PMID: 8606920BACKGROUND

  • 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.

    PMID: 33371726BACKGROUND

  • 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.

    PMID: 27760797BACKGROUND

  • 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.

    PMID: 33245708BACKGROUND

Related Links

MeSH Terms

Conditions

PainAnxiety Disorders

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Central Study Contacts

mine gökduman keleş, Midwifery

CONTACT

05055624560minegokdumankeles@gmail.com

mine gökduman keleş, PhD.

CONTACT

05055624560minegokdumankeles@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Model Details: 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). .
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Midwifery

Study Record Dates

First Submitted

October 20, 2023

First Posted

November 1, 2023

Study Start

October 19, 2023

Primary Completion

December 30, 2023

Study Completion

December 30, 2023

Last Updated

November 1, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)