The Effect Of Machine-Based And Manually Applied Hand Massage On Pain, Anxiety And Gastrointestinal System Functions After Laparoscopic Cholecystectomy Surgery

NCT05636475 | Unknown

• 1 other identifier: 2022-SBB-0329
• Study Type: interventional
• Target: 171
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: As after almost every surgical procedure, changes in the patient's system functions, acute pain and an increase in anxiety level occur after laparoscopic cholecystectomy. Uncontrolled pain and anxiety slows down the healing process, increases the possibility of opioid use and the risk of undesirable side effects, and increases mortality, and prolongs hospital discharge. Objective: The aim of the thesis study is to evaluate the effect of machine-based and manual hand massage applied in the postoperative period on pain, anxiety and gastrointestinal system functions in patients who have undergone laparoscopic cholecystectomy. Method: In the study planned as a randomized controlled experimental study; There will be 3 groups, 57 patients in each group, including the experimental groups and the control group, who have undergone laparoscopic cholecystectomy and hospitalized in the General Surgery Clinic of Bartın State Hospital, where machine-based and manual hand massage will be applied. In addition to the analgesic treatment requested by the physician at the 0th, 4th and 8th hours after the surgery, the experimental groups will be given 10 minutes of hand massage to each hand, and only the requested treatment will be applied to the control group. After the applications, the changes in the pain and anxiety levels of the patients as well as the effects on the gastrointestinal system functions will be recorded. 'Data Collection Form', 'Numerical Rating Scale', 'State-Trait Anxiety Scale' and 'Gastrointestinal functions monitoring form' will be used to collect the data and the data will be analyzed in SPSS 22.0 program.

Conditions

Laparoscopic Cholecystectomy

Keywords

Laparoscopic cholecystectomy; hand massage; postoperative anxiety; postoperative pain; gastrointestinal tract function; machine-based

Outcome Measures

Primary Outcomes (39)

• The Effect of Machine-Based and Manually Applied Hand Massage on Pain After Laparoscopic Cholecystectomy Surgery

  To see the effect of manual hand massage

  It will be evaluated using the numerical rating scale (NRS) before the massage. A score of 0-10 is given on the NRS. A score of 0 on NRS means I have no pain. A score of 10 means I have unbearable pain.

• The Effect of Machine-Based and Manually Applied Hand Massage on Pain After Laparoscopic Cholecystectomy Surgery

  To see the effect of manual hand massage

  It will be evaluated using the numerical rating scale (NRS) after the hand massage applied at the 0th hour. A score of 0-10 is given on the NRS. A score of 0 on NRS means no pain. 10 points means unbearable pain.

• The Effect of Machine-Based and Manually Applied Hand Massage on Pain After Laparoscopic Cholecystectomy Surgery

  To see the effect of manual hand massage

  It will be evaluated using the numerical rating scale (NRS) after the hand massage applied at the 4th hour. A score of 0-10 is given on the NRS. A score of 0 on NRS means no pain. 10 points means unbearable pain.

• The Effect of Machine-Based and Manually Applied Hand Massage on Pain After Laparoscopic Cholecystectomy Surgery

  To see the effect of manual hand massage

  It will be evaluated using the numerical rating scale (NRS) after the hand massage applied at the 8th hour. A score of 0-10 is given on the NRS. A score of 0 on NRS means no pain. 10 points means unbearable pain.

• The Effect of Machine-Based and Manually Applied Hand Massage on Pain After Laparoscopic Cholecystectomy Surgery

  To see the effect of machine-based hand massage

  It will be evaluated using the numerical rating scale (NRS) before the massage. A score of 0-10 is given on the NRS. A score of 0 on NRS means I have no pain. A score of 10 means I have unbearable pain.

• The Effect of Machine-Based and Manually Applied Hand Massage on Pain After Laparoscopic Cholecystectomy Surgery

  To see the effect of machine-based hand massage

  It will be evaluated using the numerical rating scale (NRS) after the hand massage applied at the 0th hour. A score of 0-10 is given on the NRS. A score of 0 on NRS means no pain. 10 points means unbearable pain.

• The Effect of Machine-Based and Manually Applied Hand Massage on Pain After Laparoscopic Cholecystectomy Surgery

  To see the effect of machine-based hand massage

  It will be evaluated using the numerical rating scale (NRS) after the hand massage applied at the 4th hour. A score of 0-10 is given on the NRS. A score of 0 on NRS means no pain. 10 points means unbearable pain.

• The Effect of Machine-Based and Manually Applied Hand Massage on Pain After Laparoscopic Cholecystectomy Surgery

  To see the effect of machine-based hand massage

  It will be evaluated using the numerical rating scale (NRS) after the hand massage applied at the 8th hour. A score of 0-10 is given on the NRS. A score of 0 on NRS means no pain. 10 points means unbearable pain.

• The Effect of Machine-Based and Manually Applied Hand Massage on Pain After Laparoscopic Cholecystectomy Surgery

  assessing patients who are not massaged (control group)

  Immediately after surgery, it will be evaluated using the numerical rating scale. A score of 0-10 is given on the NRS. A score of 0 on NRS means I have no pain. A score of 10 means I have unbearable pain.

• The Effect of Machine-Based and Manually Applied Hand Massage on Pain After Laparoscopic Cholecystectomy Surgery

  assessing patients who are not massaged (control group)

  After surgery at 0 hour it will be evaluated using a numerical rating scale. A score of 0-10 is given on the NRS. A score of 0 on NRS means I have no pain. A score of 10 means I have unbearable pain.

• The Effect of Machine-Based and Manually Applied Hand Massage on Pain After Laparoscopic Cholecystectomy Surgery

  assessing patients who are not massaged (control group)

  After surgery at 4 hour it will be evaluated using a numerical rating scale. A score of 0-10 is given on the NRS. A score of 0 on NRS means I have no pain. A score of 10 means I

• The Effect of Machine-Based and Manually Applied Hand Massage on Pain After Laparoscopic Cholecystectomy Surgery

  assessing patients who are not massaged (control group)

  After surgery at 8 hour it will be evaluated using a numerical rating scale. A score of 0-10 is given on the NRS. A score of 0 on NRS means I have no pain. A score of 10 means I

• The Effect of Machine-Based and Manually Applied Hand Massage on Anxiety After Laparoscopic Cholecystectomy Surgery

  To see the effect of manual hand massage on state anxiety level

  The State Anxiety Scale is used. The State Anxiety Scale will be used immediately after the surgery and before the massage to be performed at the 0th hour.

• The Effect of Machine-Based and Manually Applied Hand Massage on Anxiety After Laparoscopic Cholecystectomy Surgery

  To see the effect of manual hand massage on state anxiety level

  The State Anxiety Scale is used. The State Anxiety Scale will be used after the massage performed at the 0th hour after the surgery.

• The Effect of Machine-Based and Manually Applied Hand Massage on Anxiety After Laparoscopic Cholecystectomy Surgery

  To see the effect of manual hand massage on state anxiety level

  The State Anxiety Scale is used. The State Anxiety Scale will be used after the massage performed at the 4th hour after the surgery.

• The Effect of Machine-Based and Manually Applied Hand Massage on Anxiety After Laparoscopic Cholecystectomy Surgery

  To see the effect of manual hand massage on state anxiety level

  The State Anxiety Scale is used. The State Anxiety Scale will be used after the massage performed at the 8th hour after the surgery.

• The Effect of Machine-Based and Manually Applied Hand Massage on Anxiety After Laparoscopic Cholecystectomy Surgery

  To see the effect of manual hand massage on trait anxiety level

  The Trait Anxiety Scale is used. The Trait Anxiety Scale will be used once before the surgery.

• The Effect of Machine-Based and Manually Applied Hand Massage on Anxiety After Laparoscopic Cholecystectomy Surgery

  To see the effect of machine-based hand massage on state anxiety level

  The State Anxiety Scale is used. The State Anxiety Scale will be used immediately after the surgery and before the massage to be performed at the 0th hour.

• The Effect of Machine-Based and Manually Applied Hand Massage on Anxiety After Laparoscopic Cholecystectomy Surgery

  To see the effect of machine-based hand massage on state anxiety level

  The State Anxiety Scale is used. The State Anxiety Scale will be used after the massage performed at the 0th hour after the surgery.

• The Effect of Machine-Based and Manually Applied Hand Massage on Anxiety After Laparoscopic Cholecystectomy Surgery

  To see the effect of machine-based hand massage on state anxiety level

  The State Anxiety Scale is used. The State Anxiety Scale will be used after the massage performed at the 4th hour after the surgery.

• The Effect of Machine-Based and Manually Applied Hand Massage on Anxiety After Laparoscopic Cholecystectomy Surgery

  To see the effect of machine-based hand massage on state anxiety level

  The State Anxiety Scale is used. The State Anxiety Scale will be used after the massage performed at the 8th hour after the surgery.

• The Effect of Machine-Based and Manually Applied Hand Massage on Anxiety After Laparoscopic Cholecystectomy Surgery

  To see the effect of machine-based hand massage on trait anxiety level

  The Trait Anxiety Scale is used. The Trait Anxiety Scale will be used once before the surgery.

• The Effect of Machine-Based and Manually Applied Hand Massage on Anxiety After Laparoscopic Cholecystectomy Surgery

  Evaluation of state anxiety level of patients who were not massaged (control group)

  Immediately after surgery the State Anxiety Scale is used.

• The Effect of Machine-Based and Manually Applied Hand Massage on Anxiety After Laparoscopic Cholecystectomy Surgery

  Evaluation of state anxiety level of patients who were not massaged (control group)

  After surgery at 0th hour the State Anxiety Scale is used.

• The Effect of Machine-Based and Manually Applied Hand Massage on Anxiety After Laparoscopic Cholecystectomy Surgery

  Evaluation of state anxiety level of patients who were not massaged (control group)

  After surgery at 4th hour the State Anxiety Scale is used.

• The Effect of Machine-Based and Manually Applied Hand Massage on Anxiety After Laparoscopic Cholecystectomy Surgery

  Evaluation of state anxiety level of patients who were not massaged (control group)

  After surgery at 8th hour the State Anxiety Scale is used.

• The Effect of Machine-Based and Manually Applied Hand Massage on Anxiety After Laparoscopic Cholecystectomy Surgery

  Evaluation of trait anxiety level of patients who were not massaged (control group)

  The Trait Anxiety Scale is used. The Trait Anxiety Scale will be used once before the surgery.

• The Effect of Machine-Based and Manually Applied Hand Massage on Gastrointestinal System Functions After Laparoscopic Cholecystectomy Surgery

  To see the effect of manual hand massage

  The form of monitoring of gastrointestinal functions is used. Before the massage, it will be evaluated using a The form of monitoring of gastrointestinal functions.

• The Effect of Machine-Based and Manually Applied Hand Massage on Gastrointestinal System Functions After Laparoscopic Cholecystectomy Surgery

  To see the effect of manual hand massage

  The form of monitoring of gastrointestinal functions is used. After the hand massage applied at 0th hour, it will be evaluated using a The form of monitoring of gastrointestinal functions.

• The Effect of Machine-Based and Manually Applied Hand Massage on Gastrointestinal System Functions After Laparoscopic Cholecystectomy Surgery

  To see the effect of manual hand massage

  The form of monitoring of gastrointestinal functions is used. After the hand massage applied at 4th hour, it will be evaluated using a The form of monitoring of gastrointestinal functions.

• The Effect of Machine-Based and Manually Applied Hand Massage on Gastrointestinal System Functions After Laparoscopic Cholecystectomy Surgery

  To see the effect of manual hand massage

  The form of monitoring of gastrointestinal functions is used. After the hand massage applied at 8th hour, it will be evaluated using a The form of monitoring of gastrointestinal functions.

• The Effect of Machine-Based and Manually Applied Hand Massage on Gastrointestinal System Functions After Laparoscopic Cholecystectomy Surgery

  To see the effect of machine-based hand massage

  The form of monitoring of gastrointestinal functions is used. Before the massage, it will be evaluated using a The form of monitoring of gastrointestinal functions.

• The Effect of Machine-Based and Manually Applied Hand Massage on Gastrointestinal System Functions After Laparoscopic Cholecystectomy Surgery

  To see the effect of machine-based hand massage

  The form of monitoring of gastrointestinal functions is used. After the hand massage applied at 0th hour, it will be evaluated using a The form of monitoring of gastrointestinal functions.

• The Effect of Machine-Based and Manually Applied Hand Massage on Gastrointestinal System Functions After Laparoscopic Cholecystectomy Surgery

  To see the effect of machine-based hand massage

  The form of monitoring of gastrointestinal functions is used. After the hand massage applied at 4th hour, it will be evaluated using a The form of monitoring of gastrointestinal functions.

• The Effect of Machine-Based and Manually Applied Hand Massage on Gastrointestinal System Functions After Laparoscopic Cholecystectomy Surgery

  To see the effect of machine-based hand massage

  The form of monitoring of gastrointestinal functions is used. After the hand massage applied at 8th hour, it will be evaluated using a The form of monitoring of gastrointestinal functions.

• The Effect of Machine-Based and Manually Applied Hand Massage on Gastrointestinal System Functions After Laparoscopic Cholecystectomy Surgery

  assessing patients who are not massaged (control group)

  immediately after surgery, it will be evaluated using a The form of monitoring of gastrointestinal functions.

• The Effect of Machine-Based and Manually Applied Hand Massage on Gastrointestinal System Functions After Laparoscopic Cholecystectomy Surgery

  assessing patients who are not massaged (control group)

  After surgery at 0th hour, it will be evaluated using a The form of monitoring of gastrointestinal functions.

• The Effect of Machine-Based and Manually Applied Hand Massage on Gastrointestinal System Functions After Laparoscopic Cholecystectomy Surgery

  assessing patients who are not massaged (control group)

  After surgery at 4th hour, it will be evaluated using a The form of monitoring of gastrointestinal functions.

• The Effect of Machine-Based and Manually Applied Hand Massage on Gastrointestinal System Functions After Laparoscopic Cholecystectomy Surgery

  assessing patients who are not massaged (control group)

  After surgery at 8th hour, it will be evaluated using a The form of monitoring of gastrointestinal functions.

Study Arms (3)

Manuel hand massage group

EXPERIMENTAL

According to the hand massage training received, the patient coming out of the surgery is in diamond shape for ten minutes for each hand.

Other: Manual hand massage after laparoscopic cholecystectomy surgery

machine-based hand massage

EXPERIMENTAL

The pressure setting of the machine is made according to the manual massage application method. In manual massage and machine massage, machine adjustments are made to keep the temperature and pressure difference as low as possible. A hand massage is done for ten minutes for each hand.

Other: Machine-based hand massage after laparoscopic cholecystectomy surgery

Control group

NO INTERVENTION

The control group will be treated only according to the clinical analgesia protocol.

Interventions

Manual hand massage after laparoscopic cholecystectomy surgery OTHER

Manual hand massage is applied to a group of patients at 0, 4 and 8 hours after the patient returns from laparoscopic cholecystectomy surgery. It is applied to each hand for ten minutes.

Manuel hand massage group

Machine-based hand massage after laparoscopic cholecystectomy surgery OTHER

Machine-based hand massage is applied to a group of patients at 0, 4 and 8 hours after the patient returns from laparoscopic cholecystectomy surgery. It is applied to each hand for ten minutes.

machine-based hand massage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years and over,
• Having undergone laparoscopic cholecystectomy,
• No complications after laparoscopic cholecystectomy,
• Receiving analgesia treatment according to the clinical protocol,
• Pain score \>4 according to the Numerical Rating Scale,
• Able to speak and understand Turkish
• No visual or auditory problems,
• No diagnosed psychiatric problem,
• No diagnosed gastrointestinal problem,
• Voluntary patients will be included.

You may not qualify if:

• Having undergone open cholecystectomy,
• Complications after laparoscopic cholecystectomy,
• Pain score ≤4 according to the Numerical Rating Scale,
• Using analgesic drugs or methods other than clinical protocol,
• Having visual or auditory problems,
• Having a diagnosed psychiatric problem,
• Diagnosed gastrointestinal problem,
• Patients with contagious skin disease (such as zoster, fungus, wart, eczema) on their hands, presence of thrombosis or phlebitis, any fracture, ligament injury,
• Non-voluntary patients will be excluded.

Sponsors & Collaborators

• Münevver Şengül: lead
• Bartin State Hospital: collaborator

Study Sites (1)

Bartin universty

Bartın, 74100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Münevver Şengül

  mnvvrsngll58@gmail.com

  PRINCIPAL INVESTIGATOR

• Sevim Çelik

  sevimakcel@yahoo.com

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor Investigator

Model Details: Randomized controlled experimental study

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: December 5, 2022
• Study Start: October 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: September 1, 2023
• Last Updated: December 6, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)