- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
62
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Esenyurt
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Istanbul, Esenyurt, Turkiet (Türkiye), 3434
- Istanbul Esenyurt Necmi Kadıoğlu State Hospital
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Ja
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Visual Analog Scale (VAS)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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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Samarbetspartners och utredare
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Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
30 april 2025
Primärt slutförande (Faktisk)
1 juni 2025
Avslutad studie (Faktisk)
25 oktober 2025
Studieregistreringsdatum
Först inskickad
8 maj 2026
Först inskickad som uppfyllde QC-kriterierna
6 juli 2026
Första postat (Faktisk)
9 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
9 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
6 juli 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Urogenitala sjukdomar
- Genitala sjukdomar
- Neurologiska manifestationer
- Mentala störningar
- Kvinnliga urogenitala sjukdomar
- Kvinnliga urogenitala sjukdomar och graviditetskomplikationer
- Genitala sjukdomar, kvinnor
- Patologiska tillstånd, tecken och symtom
- Tecken och symtom
- Smärta
- Ångeststörningar
- Livmodersjukdomar
Andra studie-ID-nummer
- UskudarU-SBF-AK-01
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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