Hernia, Inguinal, Anxiety, Postoperative Pain
Conditions
Brief summary
This study aims to test the effects of a Preoperative Relaxation intervention and an Intensified Surgery Patient Education on pre- and postoperative wellbeing and health in Patients Undergoing Herniotomy.
Detailed description
see above
Interventions
BEHAVIORALrelaxation program
relaxation and mindfulness techniques such as body scan, breathing meditation or imagination exercises 1 week programm, one introductory session and daily home practice
BEHAVIORALsurgery education
intensified education unit to reduce anxiety and stress, by using pictures and videos of rooms, and procedures of the planned surgery 1 single unit in the week before the surgery
Sponsors
Universität Duisburg-Essen
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* referral for herniotomy * preoperative anxiety at least 4/10 points on a numeric rating scale * physical and mental capability to participant * written informed consent
Exclusion criteria
* Emergency surgery * malignoma * recurrence of inaugural hernia * severe comorbidity * severy psychological disorders * immunosuppression * coagulation disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| preoperative anxiety (State Anxiety (STAI-S) | day of surgery | State Anxiety (STAI-S) (Spielberger 1970) |
| postoperative pain intensity (numeric rating scale) | day after the surgery, before medication | numeric rating scale for pain at rest, pain at mobilization, coughing, washing, breathing and moving |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| preoperative anxiety Amsterdam Preoperative Anxiety and Information Scale (APAIS) | day of surgery | Amsterdam Preoperative Anxiety and Information Scale (APAIS) (Berth 2007) |
| preoperative anxiety Anaesthesia- and Surgery-dependent Preoperative Anxiety (ASPA) | day of surgery | Anaesthesia- and Surgery-dependent Preoperative Anxiety (ASPA) (Wetsch 2009) |
| postoperative disability | day after surgery | interference of pain with movement, coughing, waking up at night and disturbed mood |
| postoperative fatigue Fatigue measured by 0-10 Numeric Rating Scale | Day after surgery | Fatigue measured by 0-10 Numeric Rating Scale |
| postoperative nausea Nausea measured by 0-10 Numeric Rating Scale | Day after surgery | Nausea measured by 0-10 Numeric Rating Scale |
| postoperative complications | 10 days after surgery | postoperative complications such as wound healing, haematoma, seroma, swelling, nausea, vomiting, bleeing, fever |
| Satisfaction with care | 10 days after surgery | Satisfaction with the operation, the hospital care |
| Satisfaction with interventions | 10 days after surgery | Satisfaction with the interventions |
| preoperative anxiety Trait Anxiety (STAI-T) | day of surgery | (Spielberger 1970) |
Other
| Measure | Time frame | Description |
|---|---|---|
| course of surgery | day of surgery | blood pressure, use of medication during operation, amount of gases during insufflation |
Countries
Germany
Contacts
Primary ContactGustav Dobos, Prof, MD
Outcome results
None listed