- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT07797296
Predictors of Religious Orientation Attitudes in Menopausal Women (MENO-RO)
Predictors of Attitudes Toward Religious Orientation in Menopausal Women: A Cross-Sectional Study
Studie Overzicht
Toestand
Gedetailleerde beschrijving
Background:
Menopause is a multidimensional transition in a woman's life with biological, psychological, social and spiritual dimensions. With increasing life expectancy, women spend roughly a third of their lives in the menopausal period. The decline in oestrogen is associated with hot flushes, sleep disturbance, mood fluctuations and sexual dysfunction, which can adversely affect quality of life. The literature emphasises that the menopause experience is shaped not only biologically but also by sociocultural factors and religious beliefs, and that religious and spiritual orientation can increase psychological resilience and reduce anxiety and stress. Sexual dysfunction is highly prevalent in this period, and sexuality is closely linked to lifestyle, cultural roles, religious beliefs and societal myths; low sexual awareness and adoption of sexual myths may intensify the perceived severity of menopausal symptoms.
Aim:
To determine the predictive effect of the physical and psychological symptoms of menopause and of attitudes toward sexual myths on the intrinsic religious orientation of menopausal women.
Design and setting:
Descriptive, cross-sectional design. The study population comprises healthy women aged 49 to 59 with a diagnosis of menopause and no chronic health problem, presenting to a health facility in Konya, Turkey. The sample consists of women who meet the inclusion criteria and volunteer to participate.
Sample size:
Calculated with G*Power 3. For a linear multiple regression model with a medium effect size of 0.15, power of 0.95 and a Type I error of 0.05, a minimum of 89 participants is required. Allowing for a possible 10 percent data loss, 97 participants are planned.
Measures:
A personal information form (15 items covering sociodemographic and obstetric characteristics), the Menopause Rating Scale (MRS), the Intrinsic Religious Orientation Scale and the Sexual Myths Scale. Written informed consent is obtained; author permissions for the scales are obtained by email. Data are collected face to face.
Statistical analysis:
Analyses are performed with IBM SPSS Statistics v29.0. Normality is assessed with visual and analytical methods (Kolmogorov-Smirnov test). Descriptive statistics are reported as mean and standard deviation or median (minimum to maximum) as appropriate. Multiple regression models are built to estimate regression coefficients and 95 percent confidence intervals for the relationships between religious orientation and age, number of pregnancies, menopause duration, menopause symptom severity and sexual myths. Group comparisons use the Mann-Whitney U and Kruskal-Wallis tests where appropriate. Significance is set at p less than 0.05.
Ethics:
Institutional permission and ethics approval will be obtained from the Non-Drug and Non-Medical Device Research Ethics Board of KTO Karatay University before the study begins. Written informed consent is obtained from all participants.
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: Hasan Gercek, PhD
- Telefoonnummer: +90 542 648 8455
- E-mail: hasan.gercek@acibadem.edu.tr
Studie Locaties
-
-
-
Konya, Turkije (Türkiye)
- Werving
- Recruitment site (to be specified), Konya
-
Contact:
- Aslihan Turan
-
Hoofdonderzoeker:
- Aslihan Turan
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- Woman aged 49 to 59 years
- Diagnosis of menopause
- No chronic health problem
- Volunteers to participate and provides written informed consent
Exclusion Criteria:
* Presence of a chronic disease (e.g. cardiac disease, diabetes, hypertension)
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
|---|
|
Menopausal women aged 49 to 59
Healthy women aged 49 to 59 with a diagnosis of menopause and no chronic disease (such as cardiac disease, diabetes or hypertension), recruited in Konya, Turkey, who volunteer to participate.
Participants complete a single battery of self-report scales collected face to face; no intervention is applied.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Intrinsic religious orientation (Intrinsic Religious Orientation Scale)
Tijdsspanne: Single assessment at enrollment (Day 1)
|
The Intrinsic Religious Orientation Scale (Hoge, 1972; Turkish standardisation by Karaca, 2001) contains 10 items measuring intrinsic religious motivation.
Seven items are positively worded and three are negatively worded and reverse coded.
Items are rated on a 5-point Likert format scored from 0 (weakest) to 4 (strongest), giving a total score of 0 to 40, with higher scores indicating stronger intrinsic religious orientation.
|
Single assessment at enrollment (Day 1)
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Menopausal symptom severity (Menopause Rating Scale, MRS)
Tijdsspanne: Single assessment at enrollment (Day 1)
|
The Menopause Rating Scale (Schneider et al., 2000; Turkish adaptation by Can Gurkan, 2005) is an 11-item scale with three subscales: somatic complaints, psychological complaints and urogenital complaints.
Each item is rated on a 5-point scale from 0 (none) to 4 (very severe), giving a total score of 0 to 44, with higher scores indicating greater symptom severity.
|
Single assessment at enrollment (Day 1)
|
|
Sexual myths (Sexual Myths Scale, SMS)
Tijdsspanne: Single assessment at enrollment (Day 1)
|
The Sexual Myths Scale (Golbasi et al., 2016) is a 28-item, 5-point Likert scale with eight subscales (sexual orientation, gender, age and sexuality, sexual behaviour, masturbation, sexual violence, sexual intercourse and sexual satisfaction).
The total score ranges from 28 to 140, with higher scores indicating a greater likelihood of holding sexual myths.
|
Single assessment at enrollment (Day 1)
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Aslihan Turan, KTO Karatay University
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- MENO-RELIG-2026
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .