- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07694037
The Effect of Progressive Muscle Relaxation Exercise Applied Before Endometrial Biopsy on Pain, Anxiety Level and Patient Comfort in Premenopausal Women
6. juli 2026 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
62
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Esenyurt
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Istanbul, Esenyurt, Tyrkia (Türkiye), 3434
- Istanbul Esenyurt Necmi Kadıoğlu State Hospital
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske 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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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.
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progressive muscle relaxation exercise
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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.
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progressive muscle relaxation exercise
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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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).
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2 months
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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).
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2 months
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General Comfort Questionaire (GCQ)
Tidsramme: 2 months
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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.
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2 months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Yoo SA, Kim CY, Kim HD, Kim SW. Effects of progressive muscle relaxation therapy with home exercise on pain, fatigue, and stress in subjects with fibromyalgia syndrome: A pilot randomized controlled trial. J Back Musculoskelet Rehabil. 2022;35(2):289-299. doi: 10.3233/BMR-191703.
- Turan GB, Ozer Z, Sarikose A. The effects of progressive muscle relaxation exercise applied to lung cancer patients receiving chemotherapy on dyspnea, pain and sleep quality: A randomized controlled trial. Eur J Oncol Nurs. 2024 Jun;70:102580. doi: 10.1016/j.ejon.2024.102580. Epub 2024 Apr 1.
- Vitale SG, Buzzaccarini G, Riemma G, Pacheco LA, Di Spiezio Sardo A, Carugno J, Chiantera V, Torok P, Noventa M, Haimovich S, De Franciscis P, Perez-Medina T, Angioni S, Lagana AS. Endometrial biopsy: Indications, techniques and recommendations. An evidence-based guideline for clinical practice. J Gynecol Obstet Hum Reprod. 2023 Jun;52(6):102588. doi: 10.1016/j.jogoh.2023.102588. Epub 2023 Apr 13.
Hjelpsomme linker
Studierekorddatoer
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Studer hoveddatoer
Studiestart (Faktiske)
30. april 2025
Primær fullføring (Faktiske)
1. juni 2025
Studiet fullført (Faktiske)
25. oktober 2025
Datoer for studieregistrering
Først innsendt
8. mai 2026
Først innsendt som oppfylte QC-kriteriene
6. juli 2026
Først lagt ut (Faktiske)
9. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
9. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
6. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Urogenitale sykdommer
- Kjønnssykdommer
- Nevrologiske manifestasjoner
- Psykiske lidelser
- Kvinnelige urogenitale sykdommer
- Kvinnelige urogenitale sykdommer og graviditetskomplikasjoner
- Kjønnssykdommer, kvinner
- Patologiske tilstander, tegn og symptomer
- Tegn og symptomer
- Smerte
- Angstlidelser
- Livmorsykdommer
Andre studie-ID-numre
- UskudarU-SBF-AK-01
Plan for individuelle deltakerdata (IPD)
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