The Effect of Foot Massage on Anxiety, Pain and Comfort Level

NCT05850897 | Active Not Recruiting

• 1 other identifier: *SBU,SR,NSBÇ-44*
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Aim and objectives:The aim of this study is to examine the effect of foot massage on reducing pain and anxiety and increasing the comfort level in patients undergoing laparoscopic cholecystectomy. Design:The study is a randomized controlled experimental study with a pretest posttest control group. Methods:This study will be carried out in Niğde Ömer Halisdemir University Training and Research Hospital General Surgery Clinic. Participants were divided into massage group and control group. Vital signs of the massage group will be taken 2 hours before the operation and Surgical Anxiety Scale will be applied to adult patients (n=40). At this stage, the patient's both feet will be massaged for a total of 20 minutes, 10 minutes each. Vital signs and anxiety status of the patients will be evaluated 30 minutes after the procedure. Postoperative vital signs, pain severity, anxiety and comfort level will be evaluated and after the evaluation, a foot massage will be applied to both feet of the patient for 10 minutes, for a total of 20 minutes. Vital signs and pain levels of the patients will be evaluated at the 5th, 30th, 60th, 90th and 120th minutes after the massage, and their comfort and anxiety levels will be evaluated at the 30th minute. The same data will be collected from patients in the control group (n=40) without foot massage. Data will be collected from Patient Descriptive Information Form, Vital Signs Follow-up Form, Surgical Anxiety Scale for Adult Patients, Perianesthesia Comfort Scale, Numerical Pain Scale.will be used.

Conditions

Pain; Anxiety

Keywords

Cholessystectomy; Foot massage; Comfort

Outcome Measures

Primary Outcomes (1)

• Perianesthesia Comfort Scale

  PCS consisting of 24 items and before the individual's surgery, it is a 6-point Likert-type scale that questions their general thoughts and feelings about the process during and after. The scale scoring varies between 1 and 6 points Dec, the scale questions are scored as 1= "I Strongly Disagree" 6= "I Strongly Agree".The highest total score of PCS is 144 and the lowest total score is 24.

  Two days

Secondary Outcomes (1)

• Numerical Pain Scale

  Two days

Other Outcomes (1)

• Surgical Anxiety Scale for Adult Patients

  Two days

Study Arms (2)

Massage Group

EXPERIMENTAL

Appropriate position is given to the patients. Thumb and finger movements, patting, rubbing and squeezing techniques are used in foot massage. During training, the active hand applies pressure, while the passive hand uses both hands to support the foot. The intervention begins with rubbing and warming the feet. The duration of the foot warming process is approximately 5 minutes, and after the foot warming maneuvers, the methods of moving the thumbs of both hands towards the soles of the feet and spinning the laundry are used. The inner and outer parts of the foot are patted in a balanced way. This caressing movement on both feet is done with these movements in a light and rhythmic way and the massage is completed. Data will be obtained with Patient Descriptive Information Form, Vital Signs Follow-up Form, Surgical Anxiety Scale for Adult Patients, Perianesthesia Comfort Scale, Numerical Pain Scale.

Other: Masaj

Control Group

NO INTERVENTION

Massage will not be applied to the control group; intervention scales will be applied by taking vital signs after waiting until the massage application in the group (20 minutes in total) and the rest period (30 minutes).

Interventions

Masaj OTHER

Appropriate position is given to the patients. Thumb and finger movements, patting, rubbing and squeezing techniques are used in foot massage. During training, the active hand applies pressure, while the passive hand uses both hands to support the foot. The intervention begins with rubbing and warming the feet. The duration of the foot warming process is approximately 5 minutes, and after the foot warming maneuvers, the methods of moving the thumbs of both hands towards the soles of the feet and spinning the laundry are used. The inner and outer parts of the foot are patted in a balanced way. This caressing movement on both feet is done with these movements in a light and rhythmic way and the massage is completed. Data will be obtained with Patient Descriptive Information Form, Vital Signs Follow-up Form, Surgical Anxiety Scale for Adult Patients, Perianesthesia Comfort Scale, Numerical Pain Scale.

Massage Group

Eligibility Criteria

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

You may qualify if:

• Who volunteered to participate in the study,
• those who are 18 years of age or older,
• Without communication difficulties and mental disabilities related to vision, hearing and speech,
• Hypertension problem has been controlled,
• Blood pressure measurement does not need to be performed on an outpatient basis,
• Any complications after surgery (bleeding, nausea, vomiting, etc.) that did not occur,
• Application of cholecystectomy surgery,
• Having a pain assessment score of 4 and above after surgical intervention,
• For patients in the experimental group; infectious disease on the skin, local infection, open lesion/wound, scar tissue, edema,hematoma, thrombophlebitis, deep vein thrombosis, lymphangitis, coagulation disorder, varicose veins, osteoporosis, osteomyelitis, hepatitis, inflammatory and degenerative joint diseases, advanced neuropathy due to diabetes, on the toes deformity, November, who has not recently experienced fractures, dislocations, ruptures of muscle fibers, tendons or fascia,
• Analgesic is not applied before the first attempt, which is planned to be applied after the operation,
• Any medication, etc. without substance abuse,
• \* No chronic pain in any part of the body,
• All patients who are not pregnant will be included in the sample.

You may not qualify if:

• Any complications such as severe bleeding, nausea, vomiting develop after surgical intervention.,
• Patient-controlled analgesia (HKA) is applied for pain control after surgical intervention
• Patients who have at least one drain placed at the surgical site are excluded from the sample, as this may affect the level of pain he will be released.
• Termination Criteria: The individual feels uncomfortable during the application or to leave the study if he wants, the work will be terminated.

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Nesibe Sultan ÇINAROĞLU

Niğde, 51240, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Study Record Dates

• First Submitted: April 17, 2023
• First Posted: May 9, 2023
• Study Start: April 30, 2024
• Primary Completion: June 1, 2024
• Study Completion: December 30, 2024
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)