RECOVARI – Efficacy and Safety of Massage on Surgical Stress in Colorectal Cancer Patients: Study Protocol for A Randomized Controlled, Three-Arm Parallel Group, Clinical Trial

Abstract

• Background: Patients’ physiological stress reactions to surgery have been ameliorated by refining surgical techniques, and improving pain therapy. Moreover, another way to reduce stress could be the use of Rhythmical embrocation (RE), a type of bodily massage applied with soft strokes, which has been shown to reduce the subject’s pulse rate and blood pressure. This trial will investigate whether RE is effective to reduce stress, and what effects it exerts on sleep quality, nausea and vomiting, pain, medication consumption, mood, mobility, and length of hospital. Furthermore, the occurrence of complications associated with RE will be established. • Methods: A randomized controlled, three-arm parallel group trial will include 60 patients with colorectal cancer scheduled for surgery, randomized into three different intervention groups: (1) RE performed by professionals, (2) RE performed by students; and (3) empathic conversation. The intervention will be performed twice daily over four consecutive postoperative days. Before and after the intervention days, heart rate variability (primary outcome) will be established overnight as a measure of stress. The patients will fill out questionnaires on pain, sleep, nausea/vomiting and well-being. Possible complications from RE will be recorded daily. Vital signs, medication and surgery data will be retrieved from the patient record. Nursing students will be interviewed about job satisfaction, empathy and their identification with RE.• Discussion: Massage has been shown to have stress relieving effects. However, it’s effectiveness in clinical settings is rarely investigated. With the postoperative setting we investigate massage in a situation of high physiological stress. Reduction of stress perioperatively has shown to reduce complications and improve recovery. With heart rate variability we include a physiologic, objective parameter to supplement them against the questionnaire responses of patients. Massage might reduce stress in stressful situations in healthcare and contribute to a better outcome of these patients. Trial registration: The trial has been registered in the German Clinical Trials Register (DRKS) under the ID DRKS00023407 on 2nd November 2020. The trial was approved by the ethics committee of the University Medical Center Freiburg under the number 356/20 on 20th October 2020.

RECOVARI – Postoperative massage in colorectal cancer patients: a randomized controlled, three-arm parallel group trial

“…The protocol is available as a preprint publication. [47] Funding Authors' contributions All authors contributed to the study conception and design. Material preparation, data collection and analysis were performed by PGW, DC, MJ, AKL and GN.…”