COMplementary Hand-foot Massage to Improve Experience of illneSs Trial

NCT ID: NCT02741401

Last Updated: 2016-04-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2016-12-31

Brief Summary

The COMplementary hand-foot Massage to Improve experience of ilneSs trial (COMMIS trial) is a prospective, randomized trial and executed at a Western referral Centre: Zuyderland Medical Centre located Sittard-Geleen, The Netherlands concerning patients who underwent surgery for gastrointestinal malignancy. During 5 consecutive days, the intervention group received postoperatively hand-foot massage administered by trained volunteers.

The aim of this study is to investigate the effect of complementary therapies concerning quality of life, pain, nausea, fatigue, sleeping problems, mood and stress in patients who underwent an operation as a result of gastrointestinal malignancy (stomach or colorectal).

Detailed Description

The COMplementary hand-foot Massage to Improve experience of ilneSs trial (COMMIS trial) is a prospective, randomized trial and executed at a Western referral Centre: Zuyderland Medical Centre located Sittard-Geleen, The Netherlands.

The aim of this study is to investigate the effect of complementary therapies concerning quality of life, pain, nausea, fatigue, sleeping problems, mood and stress in patients who underwent an operation as a result of gastrointestinal malignancy (stomach or colorectal). Patients had to be >18 years of age. Exclusion criteria were patients who were not able to undergo massage, not able to sign informed consent or speaking the native language, deaf patients and patients having a hand- or foot disorder.

Primary outcome measure is quality of life, including psychological state, level of functioning in daily life and pain. Secondary outcome measures are patient satisfaction about the received hospital care and the need for complementary medicine.

Recruitment takes place during the second preoperative appointment at the clinic, where eligible patients receive oral and written information about the study. One week after this conversation, patients are asked if they are interested to participate. If so, informed consent is obtained and remaining questions are answered.

Randomization takes place by the randomization program ALEA. It was not possible to blind investigator, patient, physician or nurse.

Patient groups consist of an intervention group (51 patients) and a control group (51 patients). The intervention group receives postoperatively during 5 consecutive days hand-foot massage from volunteers who are trained by a professional. It was not possible to receive massage in the weekends because of the absence of the volunteers. The technique comprised standard 'Swedish' massage, which means applying kneading and strokes to soft tissues and muscles. The intervention was performed by applying ethereal oils from Volatile, which consisted of 10% jojoba and 90% almond oil.

The control group receives the usual care.

Patients from both groups are asked to fill in questionnaires about health status/health related quality of life (EQ-5D-3L) and anxiety/depression (HADS-NL) at specific moments in time. Those include one week pre-operatively (baseline), post-operative day (POD) 1, POD3, POD5 and when they return at the policlinic after hospital's discharge. Before discharge, every patient is asked to fill in a questionnaire about patient satisfaction concerning the received hospital care as well.

Conditions

Gastrointestinal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Therapy standard

Patients receive usual postoperative care

Group Type: ACTIVE_COMPARATOR

Usual post-operative care

Intervention Type: OTHER

Usual post-operative care concerning patients who underwent surgery because of gastrointestinal malignancy

Therapy standard + hand-foot massage

Patients receive usual postoperative care and hand-foot massage

Group Type: EXPERIMENTAL

Usual post-operative care

Intervention Type: OTHER

Usual post-operative care concerning patients who underwent surgery because of gastrointestinal malignancy

Hand-foot massage

Intervention Type: OTHER

Hand-foot massage administered during 5 consecutive days postoperatively by trained volunteers, concerning patients who underwent surgery because of gastrointestinal malignancy

Interventions

Usual post-operative care

Usual post-operative care concerning patients who underwent surgery because of gastrointestinal malignancy

Intervention Type: OTHER

Hand-foot massage

Hand-foot massage administered during 5 consecutive days postoperatively by trained volunteers, concerning patients who underwent surgery because of gastrointestinal malignancy

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients who underwent an operation as a result of gastrointestinal malignancy (stomach or colorectal).
• Patients >18 years of age.

Exclusion Criteria

• Patients who were not able to undergo massage
• Patients who were not able to sign informed consent
• Patients who did not speak the native language
• Deaf patients
• Patients having a hand- or foot disorder.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zuyderland Medisch Centrum

OTHER

Sponsor Role: lead

Responsible Party

M.J.M.T. Wolters

Dr. J.H.M.B. Stoot

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jan H. Stoot, Dr.

Role: PRINCIPAL_INVESTIGATOR

Zuyderland MC

Other Identifiers

COMMIS

Identifier Type: -

Identifier Source: org_study_id