N80
Conditions
Interventions
Group 1: 7 days EMA (6x digital mini questionnaires and parallel saliva sampling) - 3 weeks break - 7 days EMA + intervention (3x 10-minute attention control on positive relationship aspects)
Group 2:
Sponsors
Universitätsklinikum Heidelberg
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: • Subjects with the ability to follow study instructions and likely to attend and complete all required visits • Written informed consent of the participant • Willingness of the participant to receive SMS to their own smartphones and fill out short questionnaires using the provided link • Being committed to an ongoing romantic relationship and living as a couple for at least 6 months • Subjects are able to speak, write and understand the German language sufficiently well (at the investigators discretion) to complete all required study procedures Additional inclusion criteria for patients: • Impairment due to chronic pelvic pain due to endometriosis • Age 18 – 45 • Existence of menstruation and regular cycle
Exclusion criteria
Exclusion criteria: Patients suffering from other (chronic) pain conditions, cancer, neurological, gynecologi-cal diseases, psychosis or psychoactive medication, or substance use disorders, or current pregnancy will be excluded from participation. For all participants (including partners): • Withdrawal of participant consent (defined as a study participant who explicitly takes back his or her consent) is possible at all times during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) To analyze changes in psychological, partner, hormonal and subjective pain variables during everyday social interactions of individuals with chronic pelvic pain due to endometriosis and their partners using the EMA. The variables will be used to predict the quality of social interactions and subsequent response to the intervention, dyadic covariation will be investigated. 2) Conduct and evaluate standardized instructed social interactions in couples (one partner affected by chronic pain) to improve psychological, partner, and subjective pain variables in everyday life and examine the effects on subjective and endocrine measures (oxytocin and cortisol) and dyadic covariation. This information is collected via Ecological Momentary Assessment (EMA) questionnaires. | — |
Secondary
| Measure | Time frame |
|---|---|
| Questionnaire and demographic data, such as age and social relationships, will be analyzed as covariates. The following questionairs will be used in the baseline assessment: • Sociodempgraphics • Pain Experience Scale (SES; Geissner, 1996) • Hospital Anxiety and Depression Scale (HADS-D; Herrmann-Lingen, Buss, & Snaith, 1995; Zigmond & Snaith, 1983) • Childhood Trauma Questionnaire (Bernstein & Fink, 1998; Klinitzke, Romppel, Häu-ser, Brähler, & Glaesmer, 2012); • Trier Inventory for Chronic Stress (TICS; Schulz, Schlotz, & Becker, 2004) • The Big Five Inventory (BFI-10; Rammstedt, B., & John, O. P., 2007) • The Pain Catastophizig Scale (PCS; Meyer, Sprott, & Mannion, 2008) • German Version of the Coping Strategies Questionnaire (CSQ-D; Verra, Angst, Leh-mann & Aeschlimann, 2006) • West Haven-Yale Multidimensional Pain Inventory (MPI-D; Kerns, Turk, & Rudy, 1985; Flor, Rudy, Birbaumer, Streit, & Schugens, 1990) • PainDETECT (Freynhagen, Baron & Gockel, 2006) • Touch Experiences and Attitudes Questionnaire (TEAQ, Trotter, Belovol, McGlone & Varlamov, 2018) • German Female Sexual Functioning Index (FSFI-d; Berner, Kriston, Zahradnik, Härter & Rohde, 2004) • SBQ-G - Sexual Behaviour Questionnaire - deutsche Version (FZS; Müller, 2016) • Endometriosis Health Profile Questionnaire (EPH-30; Jones, Kennedy, Barnard, Wong, & Jenkinson, 2001) • Kurzform des Partnerschaftsfragebogen (PFBK; Kliem, Job, Kröger, Bodenmann, Stöbel-Richter, Hahlweg, & Brähler, 2012) • Unidimensional Relationship Closeness Scale (URCS; Dibble, Levine, & Park, 2012) • Experiences in Close Relationships Revised questionnaire (ECR-RD; Ehrenthal, Zim-mermann, Brenk-Franz, Dinger, Schauenburg, Brähler, & Strauß, 2021) • Berlin Social Support Scale (BSSS; Schwarzer & Schulz, 2000) • Dyadic Coping Inventory (DCI; Bodenmann, 2008) | — |
Countries
Germany
Contacts
Public ContactZoe Wörner
Institut für Medizinische Psychologie, Uniklinikum
Outcome results
None listed