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The Effect of Progressive Muscle Relaxation Exercise Applied Before Endometrial Biopsy on Pain, Anxiety Level and Patient Comfort in Premenopausal Women

6. juli 2026 opdateret af: Ayşegül KARAKOÇ, Uskudar University
This study was designed to determine the effect of progressive muscle relaxation exercises performed before endometrial biopsy on pain, anxiety levels, and patient comfort in premenopausal women.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This study aims to implement progressive muscle relaxation exercises to control and minimize feelings such as pain, anxiety, and discomfort experienced by women prior to undergoing endometrial biopsy procedures for diagnostic and screening purposes during the premenopausal period. The study aims to examine whether the application of progressive muscle relaxation exercises results in a reduction in pre-procedure anxiety and an increase in comfort among women.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

62

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Tyrkiet (Türkiye)
    • Esenyurt
      • Istanbul, Esenyurt, Tyrkiet (Türkiye), 3434
        • Istanbul Esenyurt Necmi Kadıoğlu State Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

Inclusion Criteria:

  • Endometrial biopsy request must be performed using an endometrial biopsy cannula (Pipelle).
  • Aged 40 years or older with irregular cycles.
  • At least a primary school graduate.
  • No impediment to performing progressive relaxation exercises.
  • The patient's consent to participate in the study.

Exclusion Criteria:

  • Presence of any physical or mental disability.
  • The patient's refusal to participate in the study.
  • Presence of any neurological or psychiatric disorder/use of medication
  • Having entered menopause.
  • Having a disease that could prevent the exercises from being performed (musculoskeletal problems, asthma, etc.).
  • The patient having previously undergone an abortion, endometrial biopsy, or endocervical biopsy.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: progressive muscle relaxation exercise
The group will receive pre-procedure training on progressive muscle relaxation exercises prior to the study. The researcher will explain how to perform the exercise and its importance for patients for approximately 5 minutes. Patients will then be instructed to perform progressive muscle relaxation exercises in a quiet room that will not distract them, using a tablet and headphones to listen to audio instructions. The patient will be taken to a screened-off area for dressing and undressing. The examination table and surgical instruments required for the patient's procedure will be prepared in a sterile manner. When the patient is ready, she will be taken to the gynecological table and the doctor will perform an endometrial biopsy.
Adfærdsmæssigt: progressive muscle relaxation exercise
progressive muscle relaxation exercise
Aktiv komparator: control group
The patient will be taken to a private changing room. When the patient is ready, she will be taken to the gynecological table and the doctor will perform an endometrial biopsy. Patients in good general health will be taken to the changing room to get dressed and will be informed about the procedure before being directed to the doctor's office for a prescription.
Adfærdsmæssigt: progressive muscle relaxation exercise
progressive muscle relaxation exercise

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Visual Analog Scale (VAS)
Tidsramme: 2 months
Pain intensity was assessed using the Visual Analog Scale (VAS), a simple, reliable, and widely used unidimensional measure of subjective pain intensity (Hawker et al., 2011). The scale consists of a 10-cm horizontal or vertical line anchored by two descriptors representing the extremes of pain (0 = "no pain" and 10 = "worst imaginable pain"). Participants were asked to mark on the line the point that best represented their pain intensity. The score was determined by measuring the distance (in millimeters) from the "no pain" anchor to the participant's mark. It has been shown to correlate well with other clinical pain assessment tools and is frequently used in both research and clinical settings for its ease of use and sensitivity(Jensen et al., 1986).
2 months
State Anxiety Inventory (STAI Form I)
Tidsramme: 2 months
State anxiety was assessed using the State-Trait Anxiety Inventory (STAI Form I), originally developed by Spielberger and colleagues to measure situational anxiety levels. The scale consists of 20 items evaluating how individuals feel "at the moment," rated on a 4-point Likert scale (1 = not at all to 4 = very much so). The Turkish validity and reliability study was conducted by Öner and Le Compte. The scale includes both direct and reverse-scored items (10 reverse items: 1, 2, 5, 8, 10, 11, 15, 16, 19, and 20). Total scores range from 20 to 80, with higher scores indicating greater anxiety levels. In the present study, the internal consistency of the STAI was high (Cronbach's α = 0.888).
2 months
General Comfort Questionaire (GCQ)
Tidsramme: 2 months
Comfort was assessed using the General Comfort Questionnaire (GCQ), developed by Kolcaba based on the taxonomic structure of comfort theory, which includes three levels and four dimensions. The 48-item instrument is rated on a 4-point Likert scale and includes both positively and negatively worded items; negative items are reverse scored. Total scores range from 48 to 192, with higher scores indicating greater comfort. The final score is calculated by dividing the total score by the number of items, yielding a mean score between 1 and 4. The Turkish validity and reliability study was conducted by Karabacak and Kuğuoğlu, reporting a Cronbach's α of 0.85. In the present study, the internal consistency of the GCQ was excellent (Cronbach's α = 0.926). Subscale reliability coefficients were 0.915 for Relief, 0.908 for Ease, and 0.899 for Transcendence, indicating high reliability.
2 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Uskudar University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

30. april 2025

Primær færdiggørelse (Faktiske)

1. juni 2025

Studieafslutning (Faktiske)

25. oktober 2025

Datoer for studieregistrering

Først indsendt

8. maj 2026

Først indsendt, der opfyldte QC-kriterier

6. juli 2026

Først opslået (Faktiske)

9. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • UskudarU-SBF-AK-01

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Kliniske forsøg med Endometriesygdomme

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