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Randomized controlled, three-arm parallel group, clinical trial on efficacy and safety of rhythmic embrocations on post-surgical stress in colorectal cancer patients

Randomized controlled, three-arm parallel group, clinical trial on efficacy and safety of rhythmic embrocations on post-surgical stress in colorectal cancer patients - RECOVARI

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
DRKS
Registry ID
DRKS00023407
Enrollment
60
Registered
2020-11-02
Start date
2021-01-24
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C18 C19 C20

Interventions

Group 1: Rhythmical Embrocations (RE) performed by experts: Every RE will be performed using pure almond oil (approx. 2 mL per treatment) in the morning (between 8 and 10 pm) and the evening (between
safe sitting has to be achieved in this position as an obligatory prerequisite for this treatment. During this treatment, only one hand is touching the patient at one time. The treatment can be descri
the circles are clockwise at the left side of the back and anti-clockwise at the right side of the back
there is a slightly stronger touch when going down above the M. erector spinae to the middle of back (the spine is not touched within these movements)
the second movement is a line on one side of the back and then the other going down. Every movement is repeated about 3 times on every side of the back. 2. RE of the feet in the evening: The patient

Sponsors

Uniklinkum Freiburg - Institut für Infektionsprävention und Krankenhaushygiene
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients in an inpatient setting after colorectal cancer surgery 2. Awake and able to fill out questionnaires or answer questions 3. Age 18 years without upper age limit; legal competence; 4. Written informed consent obtained according to international guidelines and local laws; 5. Ability to understand the nature of the trial and the trial related procedures and to comply with them; 6. Ability to understand German language

Exclusion criteria

Exclusion criteria: 1. Severe surgical complication 2. Severe cardiologic complication 3. Sepsis 4. Cardiac diseases which interfere with the heart rate variability (HRV) analysis like severe arrhythmias or a pacing pacemaker 5. Severe psychiatric disorder 6. Pregnancy or breastfeeding 7. Clinically significant concomitant disease critically influencing the ability of the patient to protocol adequate behavior 8. Known hypersensitivity to skincare products; skin disease which could be negatively influenced by RE or chronic wounds in the area of the back or the feet 9. Detection of a pathogen that leads to compulsory isolation in hospital. 10. Participation in a clinical study within the 3 months before the start of this study or simultaneously – except studies which are not investigating therapeutic or diagnostic procedures and are not interfering with the current study.

Design outcomes

Primary

MeasureTime frame
Stress as measured with heart rate variability (SDNN) on day 6 (after last treatment)

Secondary

MeasureTime frame
Can RE 1. improve sleep quality (Richards-Campbell Sleep Questionnaire)? 2. reduce nausea (VAS)? 3. reduce vomiting Number of vomiting episodes per 24h? 4. reduce pain (VAS)? 5. reduce (pain and sleep) medication? 6. improve mood (MDBF)? 7. support faster mobilization? 8. Reduce the length of stay? 9. Are RE safe? 10. Are there differences between the groups 1 month after discharge? 11. How much do nursing care students identify with the carrying out of RE? 12. Does the carrying out of RE change work engagement and empathy of the nursing students (UWES-9)?

Countries

Germany

Contacts

Public ContactPaul Werthmann

Uniklinkum Freiburg - Institut für Infektionsprävention und Krankenhaushygiene

paul.werthmann@uniklinik-freiburg.de015771984421

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026