The Effect of Foot Massage on Pain, Sleep Quality and Early Discharge in Patients Undergoing Spinal Surgery

NCT05354830 | Completed

• 1 other identifier: IstanbulMU15
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

In recent years, it is known that the use of complementary approaches, which are accepted as a safe and effective method for maintaining health and well-being, providing relaxation/relaxation, and reducing the effects of illness, has been increasing. It is reported that massage, which originates from an instinctive need for touch and is one of the oldest treatment methods, was first described in China in the second century BC and immediately after in India and Egypt, and was widely used by other early cultures such as Arabs, Greeks, Italians and Romans. In papyruses, on rocks, and in ancient oral stories dating back 15,000 years, there is evidence of the use of hands to provide comfort and healing. It is stated that foot massage, which is one of the most frequently used massage types today, has been applied in different parts of the world such as Egypt, India and China for thousands of years. In addition to pharmacological methods, non-pharmacological complementary and alternative treatment methods are also used in the control of pain due to reasons such as dissatisfaction with traditional treatment methods, reluctance to use invasive procedures and daily analgesics, and the toxic effects of drugs. Massage provides relaxation both physically and mentally. It is thought to reduce edema by accelerating circulation, muscle tension and anxiety by the stimuli reaching the spinal cord, and pain sensation by stimulating peripheral sensory receptors.

Conditions

Spinal Fusion; Pain, Postoperative

Keywords

Foot massage; Sleep quality; Spinal surgery; Postoperative pain

Outcome Measures

Primary Outcomes (2)

• Pain Visual Analogue Scale

  The highest score that can be obtained from the visual analog scale is 10 and the lowest 0. As the higher score is obtained, the patient's pain will increase, and the result is evaluated as bad. Visual Analogue Scale scores will decrease after progressive muscle relaxation exercises. The highest score that can be obtained from the visual analog scale is 10 and the lowest 0. As the higher score is obtained, the patient's pain will increase, and the result is evaluated as bad. Visual Analogue Scale scores will decrease after progressive muscle relaxation exercises. The highest score that can be obtained from the visual analog scale is 10 and the lowest 0. As the higher score is obtained, the patient's pain will increase, and the result is evaluated as bad.

  12 months

• Sleep Richard-Campbell Sleep Questionnaire

  A score of "0-25" from the scale indicates that the scale is very bad, and a score of "76-100" indicates that the scale is very good.

  12 months

Study Arms (2)

Foot Massage

EXPERIMENTAL

Patients undergoing TPF surgery and foot massage

Other: Foot Massage

Control

NO INTERVENTION

Those who underwent TPF surgery and did not receive foot massage

Interventions

Foot Massage OTHER

Foot Massage

Foot Massage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having TPF surgery,
• Be over 18 years old,
• No nerve damage or psychiatric disease in the history,
• No central nervous system metastasis or disease,
• No irritation or ulceration in the skin area to be massaged,
• No history of deep vein thrombosis
• To be able to speak and understand Turkish and to be able to read and write,
• Patients with an ASA score of 1 and 2,
• It is voluntary to participate in the research.

You may not qualify if:

• Not wanting to leave the study for any reason,
• Patients with an ASA score of 3 and above,
• Complication development.

Sponsors & Collaborators

• Istanbul Medeniyet University: lead
• Istanbul University - Cerrahpasa: collaborator

Study Sites (1)

Sultan 2. Abdülhamid Han Training and Research Hospital

Istanbul, Üsküdar, Turkey (Türkiye)

Location

Related Publications (10)

• Abbaspoor Z, Akbari M, Najar S. Effect of foot and hand massage in post-cesarean section pain control: a randomized control trial. Pain Manag Nurs. 2014 Mar;15(1):132-6. doi: 10.1016/j.pmn.2012.07.008. Epub 2013 Jan 24.

  PMID: 23352729 BACKGROUND

• Ali ZS, Ma TS, Ozturk AK, Malhotra NR, Schuster JM, Marcotte PJ, Grady MS, Welch WC. Pre-optimization of spinal surgery patients: Development of a neurosurgical enhanced recovery after surgery (ERAS) protocol. Clin Neurol Neurosurg. 2018 Jan;164:142-153. doi: 10.1016/j.clineuro.2017.12.003. Epub 2017 Dec 8.

  PMID: 29232645 BACKGROUND

• Bagheri-Nesami M, Shorofi SA, Zargar N, Sohrabi M, Gholipour-Baradari A, Khalilian A. The effects of foot reflexology massage on anxiety in patients following coronary artery bypass graft surgery: a randomized controlled trial. Complement Ther Clin Pract. 2014 Feb;20(1):42-7. doi: 10.1016/j.ctcp.2013.10.006. Epub 2013 Oct 25.

  PMID: 24439644 BACKGROUND

• Cuschieri RJ, Morran CG, Howie JC, McArdle CS. Postoperative pain and pulmonary complications: comparison of three analgesic regimens. Br J Surg. 1985 Jun;72(6):495-8. doi: 10.1002/bjs.1800720631.

  PMID: 4016522 BACKGROUND

• Deyo RA, Mirza SK, Martin BI, Kreuter W, Goodman DC, Jarvik JG. Trends, major medical complications, and charges associated with surgery for lumbar spinal stenosis in older adults. JAMA. 2010 Apr 7;303(13):1259-65. doi: 10.1001/jama.2010.338.

  PMID: 20371784 BACKGROUND

• Emslie MJ, Campbell MK, Walker KA. Changes in public awareness of, attitudes to, and use of complementary therapy in North East Scotland: surveys in 1993 and 1999. Complement Ther Med. 2002 Sep;10(3):148-53. doi: 10.1016/s0965229902000663.

  PMID: 12568143 BACKGROUND

• Grealish L, Lomasney A, Whiteman B. Foot massage. A nursing intervention to modify the distressing symptoms of pain and nausea in patients hospitalized with cancer. Cancer Nurs. 2000 Jun;23(3):237-43. doi: 10.1097/00002820-200006000-00012.

  PMID: 10851775 BACKGROUND

• Eadie J, van de Water AT, Lonsdale C, Tully MA, van Mechelen W, Boreham CA, Daly L, McDonough SM, Hurley DA. Physiotherapy for sleep disturbance in people with chronic low back pain: results of a feasibility randomized controlled trial. Arch Phys Med Rehabil. 2013 Nov;94(11):2083-92. doi: 10.1016/j.apmr.2013.04.017. Epub 2013 May 2.

  PMID: 23643716 BACKGROUND

• Lu WA, Chen GY, Kuo CD. Foot reflexology can increase vagal modulation, decrease sympathetic modulation, and lower blood pressure in healthy subjects and patients with coronary artery disease. Altern Ther Health Med. 2011 Jul-Aug;17(4):8-14.

  PMID: 22314629 BACKGROUND

• Mahdavipour F, Rahemi Z, Sadat Z, Ajorpaz NM. The effects of foot reflexology on depression during menopause: A randomized controlled clinical trial. Complement Ther Med. 2019 Dec;47:102195. doi: 10.1016/j.ctim.2019.102195. Epub 2019 Sep 14.

  PMID: 31780002 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: It was planned as an open-label, blinded, randomized and controlled experimental study. A computer-assisted simple randomization method was used to distribute the groups homogeneously. For this purpose, 72 sets were created by using the functions available at the "https://www.random.org/integer-sets" internet address, and each of these sets included 8 participants, 4 participants from each study group. As the next operation, 72 sets were shown with 1 number each, and 9 numbers between 1 and 72 were generated using the "RANDOMLY SEARCH" function in Excel, and 9 sets to be used in randomization were randomly determined. In order to reach the sample number of 68 people, 4 participants, 2 from each study group, were selected in the final set. Thus, patients were randomly assigned to the experimental and control groups in order to reduce selection bias and control the variables that may affect the outcome parameters.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: Randomized controlled parallel groups

Study Record Dates

• First Submitted: April 17, 2022
• First Posted: April 29, 2022
• Study Start: May 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: October 1, 2023
• Last Updated: November 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)