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- Essai clinique NCT07694037
The Effect of Progressive Muscle Relaxation Exercise Applied Before Endometrial Biopsy on Pain, Anxiety Level and Patient Comfort in Premenopausal Women
6 juillet 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
62
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Esenyurt
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Istanbul, Esenyurt, Turquie (Türkiye), 3434
- Istanbul Esenyurt Necmi Kadıoğlu State Hospital
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
Oui
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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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Comparateur actif: 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.
|
progressive muscle relaxation exercise
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Visual Analog Scale (VAS)
Délai: 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
|
|
State Anxiety Inventory (STAI Form I)
Délai: 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)
Délai: 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.
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2 months
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Liens utiles
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
30 avril 2025
Achèvement primaire (Réel)
1 juin 2025
Achèvement de l'étude (Réel)
25 octobre 2025
Dates d'inscription aux études
Première soumission
8 mai 2026
Première soumission répondant aux critères de contrôle qualité
6 juillet 2026
Première publication (Réel)
9 juillet 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
9 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
6 juillet 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies urogénitales
- Maladies génitales
- Manifestations neurologiques
- Les troubles mentaux
- Maladies urogénitales féminines
- Maladies urogénitales féminines et complications de la grossesse
- Maladies génitales, femme
- Conditions pathologiques, signes et symptômes
- Signes et symptômes
- La douleur
- Troubles anxieux
- Maladies utérines
Autres numéros d'identification d'étude
- UskudarU-SBF-AK-01
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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