Clinical trial NCT06301126: Virtual Reality on Pulmonary Function After Upper Abdominal Surgeries
Official title: Effect of Virtual Reality on Pulmonary Function, Respiratory Muscle Strength and Functional Capacity After Upper Abdominal Surgeries
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Abdomen Hernia
Respiratory Complication
Keywords: Virtual reality
Pulmonary Function
Respiratory Muscle Strength
Functional Capacity
Upper abdominal surgery
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-03-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: After upper abdomen surgery, respiratory muscle dysfunction is well recognised. After laparotomy and even laparoscopy, maximum static inspiratory and expiratory pressures are lowered, and recovery can take several days. A variety of reasons have been implicated in such respiratory muscle dysfunction, including irritation and inflammation, as well as injuries near the diaphragm, resulting in local mechanical failure, reflex inhibition, and pain.

Detailed description: Virtual reality (VR) encourages an environment that attempts to create a moment of entertainment, motivation, and enjoyment with a variety of stimuli, with movements that stimulate physical and cognitive development, as well as the patient's active participation in the rehabilitation process. It is possible to assist in the alleviation of pain using the platform, at a low cost, through the playfulness given during rehabilitation, with an effective consumption of oxygen, range of motion, and use of the respiratory muscles more efficiently.

Participants with upper abdominal surgery will be randomly distributed into Group A (VR Group) which will receive VR for plus conventional physical therapy program and Group B (Control Group) which will receive conventional physical therapy program.

Eligibility criteria: Inclusion Criteria:

1. Patients undergone open upper abdominal surgery (hernia repair, cholecystectomy, large bowel removal, conventional laparotomy)
2. no prior surgical intervention for esophageal, gastric, or biliary tract resection
3. age 18-60 years
4. acceptable physical condition (permitting pulmonary function and functional capacity test).

Exclusion Criteria:

1. Cerebrovascular disease
2. use of immunosuppressants within 30 days of surgery
3. cardiovascular instability
4. chest physical therapy within the 8 weeks preceding study enrollment
5. visual impairment or hearing impairment;
6. bed-ridden patients;
7. any lung disorders
8. insulin-dependent diabetes mellitus
9. less than 6-months post thoracic or cardiac surgery
10. musculoskeletal impairment
11. cognitive disorders
12. Patients undergoing laparoscopic surgery as this induces smaller changes in the postoperative breathing mechanics than laparotomy does
13. heavy smokers or alcoholism

Primary outcomes:
measure: Forced vital capacity (FVC)
timeFrame: 8 weeks
Secondary outcomes:
measure: Forced expiratory volume in 1 second (FEV1)
timeFrame: 8 weeks
measure: Peak expiratory flow (PEF)
timeFrame: 8 weeks
measure: Respiratory muscle strength
timeFrame: 8 weeks
measure: diaphragmatic mobility
timeFrame: 8 weeks
measure: Functional capacity
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Physical Therapy
Study officials:
affiliation: Assistant professor of physical therapy for surgery, Faculty of physical therapy
name: Hadaya M Eladl, PhD
role: STUDY_CHAIR
affiliation: Assistant professor of physical therapy for basic sciences, Faculty of physical therapy
name: Nabil M Abdel-Aal, PhD
role: STUDY_DIRECTOR
References: