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Completed

NCT Number: NCT03543904

Pre-operative and Post-operative Physiotherapy in Children With Abdominal Surgery

The study will be conducted in a pediatric surgery ward, department of pediatrics. Children between the ages of 5 to 17 years who underwent for abdominal surgery will be recruited by simple random sampling. Parents of all the potential participants will receive a written explanation of the trial and given written informed consent forms to be signed prior to their child being involved in the trial. Pre- op physiotherapy education is given to one experimental group and after surgery post operative treatment is given to both the experimental groups. spirometery, 6 minute walk test, 10 meter walk test, Timed up and go test and Nine star stair climbing test will be used for data collection.

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Key information

Conditions

Age range

5 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pediatric surgery ward, Maharishi Markandeshwar Hospital, Mullana

Ambāla, Haryana, 133207, India

About this study

Pre- operative education is given to the experimental group 1 only. Pre- op. physiotherapy education includes-

Pursed lip breathing exercises × 10 repetitions Diaphragmatic breathing exercises × 10 repetitions Leg ROM (active hip and knee flexion, extension and abduction exercises) and ankle toe movements exercises × 10 repititions

Post- op. physiotherapy will be given to both the experimental groups. it includes- On Post operative day 1

Deep breathing exercises- Pursed lip breathing exercises × Diaphragmatic breathing exercises (5 repetitions × 2 sets)

Segmental breathing exercises × 5 repetitions × 2 sets Incentive spirometer 10 breaths up to 600 cc (In three sets) per session Leg Range of motion exercises (active hip and knee flexion and extension exercises) × 5 repetitions × 2 sets Ankle and toe movements× 10 repetitions × 2 sets Ambulation program High sitting minimum of 2 min Static March for 1 min Walk for 5 min. every 2 hourly

Post operative day 2 Deep breathing exercises- Pursed lip breathing exercises × Diaphragmatic breathing exercises (5 repetitions × 2 sets) Segmental breathing exercises × 5 repetitions × 2 sets Incentive spirometer 10 breaths upto 600 cc (In three sets) per sessionThoracic expansion exercises- ACBT (Active cycles of breathing techniques)

Diaphragmatic breathing (10 rep.), deep breathing (5 sec. hold), huffing x 2 repetitions twice a day Walk for 10 min. every 2 hourly

Post operative day 3 Pursed lip breathing exercises x 10 repetitions x 2 sets Incentive spirometer 10 breaths upto 900cc (In three sets) per session Thoracic expansion exercises- ACBT Diaphragmatic breathing (5-10 rep.), deep breathing (5 sec. hold), huffing x 2 repetitions twice a day Walk for 15 min. every 2 hourly

Post operative day 4 Incentive spirometer/ 10breaths upto 900cc (In three sets) per session Walk for 20 min. every 4 hourly

Post operative day 5 Incentive spirometer / 10breaths upto 1000cc (In three sets) per session Stair climbing up to 9 steps in ascending and descending pattern for 5 minutes rest in between

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children having following abdominal incision- inguinal incision, left subcostal incision, right subcostal incision, kehr incision, McBurney incision, Transverse incison, thoraco-abdominal incison, Median and paramedian incision12
  • Between ages of 5 to 17 years
  • Who follows and obeys the commands
  • Children who is willing to participate in the study

Exclusion criteria

  • Children who requires organ transplants
  • With mental retardation
  • With physical disability

Treatment and study plan

Pre-operative physiotherapy education

Procedure

Pre-operative education regarding post-operative physiotherapy intervention in children with abdominal surgery which includes,

  • Deep breathing exercises
  • Pursed lip breathing exercises
  • Diaphragmatic breathing exercises
  • Leg ROM (active hip and knee flexion, extension and abduction exercises)
  • Ankle toe movements exercises

Post-operative physiotherapy intervention

Procedure

Post-operative physiotherapy intervention which includes,

  • Deep breathing exercises
  • Pursed lip breathing exercises
  • Diaphragmatic breathing exercises
  • Leg ROM (active hip and knee flexion, extension and abduction exercises)
  • Ankle toe movements exercises

Primary outcomes

  1. Change in FVC (Liters) (spirometric measurements)

    Time frame: 3 times (recorded pre operative and post operative on day1 and 5)

    Functional vital capacity (FVC) is the maximum volume of air which can be exhaled or inspired during a forced maneuver

Secondary outcomes

  1. 6 minute walk test

    Time frame: 2 times (recorded pre operative and post operative on day 5)

    the child will be asked to walk far as possible for 6 minutes. Child will be encouraged in every minute for walking. At 6 minute, child will be asked to stop. If the participant stops at any time prior record the distance at which the oxygen saturation drops < 88%

  2. 10 meter walk test

    Time frame: 3 times (recorded pre operative and post operative on day1 and 5)

    The 10MWT assesses walking speed in meters per second over a short duration.The child will be asked to walk a set distance (10 meters). Time will be measured during walking. The distance covered is divided by the time it took the individual to walk that distance.

  3. Nine stair climbing test

    Time frame: 2 times (recorded pre operative and post operative on day 5)

    It is performed for measuring functional strength and balance through ascending and descending a set number of steps. 2min. time will be given to complete the test. The patient should use the assistive device (if any) normally used to perform the activity at the time of testing.

  4. Timed up and go test

    Time frame: 3 times (recorded pre operative and post operative on day1 and 5)

    The child starts in a seated position. The child will be tands up upon therapist's command walks 3 meters, turns around, walks back to the chair and sits down. The time stops when the child is seated.

Other outcomes

  1. Change in FEV1 (Liters) (Spirometeric measurements)

    Time frame: 3 times (recorded pre operative and post operative on day1 and 5)

    Forced expiratory volume in the first second (FEV1) Is the volume expired in the first second of maximal expiration after a full inspiration

  2. Change in FEV1/ FVC (%) (Spirometric measurements)

    Time frame: 2 times (recorded pre operative and post operative on day 5)

    It is also known as Tiffeneau pinelli index (FEV1/FVC) represents the proportion of individual's vital capacity that they are able to expire in the first second of forced expiration to full, forced vital capacity

  3. Change in PEFR (Liters) [Peak Expiratory Flow Rate (liters)] (Spirometeric measurements)

    Time frame: 3 times (recorded pre oprative and post operative on day1 and 5)

    Inspiratory vital capacity (IVC) is the maximum volume of air inhaled from the point of maximum expiration

  4. Chest expansion test

    Time frame: 3 times (recorded pre operative and post operative on day1 and 5)

    Chest expansion test measures the expansion of chest when the subject takes a deep breath. Chest expansion will be measured at 3 different levels. i.e 1.) Axillary level 2) Nipple level 3) xiphi-sternum level

Sponsors and collaborators

Lead sponsor

Asir John Samuel

Other

Registry information

Official study title

Effects of Pre- Operative Physiotherapy Education and Post Operative Physiotherapy in Children With Abdominal Surgery

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 1, 2018
Registry last updated
Apr 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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