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

Phase 2

• Conditions: C18; C19; C20; Malignant neoplasm of colon; Malignant neoplasm of rectosigmoid junction; Malignant neoplasm of rectum

• Registration Number: DRKS00023407
• Lead Sponsor: niklinkum Freiburg - Institut für Infektionsprävention und Krankenhaushygiene

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-02
• Study Completion: 2022-02-28
• Results First Posted: 2023-10-16
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 68

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

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.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Stress as measured with heart rate variability (SDNN) on day 6 (after last treatment)

Secondary Outcome Measures

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