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

NCT ID: NCT03543904

Last Updated: 2020-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2019-03-16

Brief Summary

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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.

Detailed Description

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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

Conditions

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Abdominal Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Participants were blinded towards which group they were allocated. If participants know that they were belonging to the experimental group 1 then they will be performing better than the participants in allocated in the experimental group 2.

Study Groups

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Pre-operative physiotherapy education

Pre-operative education regarding post-operative physiotherapy intervention and post-operative physiotherapy intervention in children with abdominal surgery

Group Type EXPERIMENTAL

Pre-operative physiotherapy education

Intervention Type PROCEDURE

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

1. Deep breathing exercises
2. Pursed lip breathing exercises
3. Diaphragmatic breathing exercises
4. Leg ROM (active hip and knee flexion, extension and abduction exercises)
5. Ankle toe movements exercises

Post-operative physiotherapy intervention

Intervention Type PROCEDURE

Post-operative physiotherapy intervention which includes,

1. Deep breathing exercises
2. Pursed lip breathing exercises
3. Diaphragmatic breathing exercises
4. Leg ROM (active hip and knee flexion, extension and abduction exercises)
5. Ankle toe movements exercises

Post-OP PT without Pre-OP education

Post-operative physiotherapy intervention without pre-operative education in children with abdominal surgery

Group Type EXPERIMENTAL

Post-operative physiotherapy intervention

Intervention Type PROCEDURE

Post-operative physiotherapy intervention which includes,

1. Deep breathing exercises
2. Pursed lip breathing exercises
3. Diaphragmatic breathing exercises
4. Leg ROM (active hip and knee flexion, extension and abduction exercises)
5. Ankle toe movements exercises

Interventions

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Pre-operative physiotherapy education

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

1. Deep breathing exercises
2. Pursed lip breathing exercises
3. Diaphragmatic breathing exercises
4. Leg ROM (active hip and knee flexion, extension and abduction exercises)
5. Ankle toe movements exercises

Intervention Type PROCEDURE

Post-operative physiotherapy intervention

Post-operative physiotherapy intervention which includes,

1. Deep breathing exercises
2. Pursed lip breathing exercises
3. Diaphragmatic breathing exercises
4. Leg ROM (active hip and knee flexion, extension and abduction exercises)
5. Ankle toe movements exercises

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asir John Samuel

OTHER

Sponsor Role lead

Responsible Party

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Asir John Samuel

Associate Professor and Research Scholar

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Neha Sharma, BPT, MPT

Role: PRINCIPAL_INVESTIGATOR

Maharishi Markandeshwar institute of physiotherapy and Rehabilitation, MM(DU)

Satya Sree, MS, MCh

Role: STUDY_DIRECTOR

HOD, Department of Pediatric surgery, MMIMSR, MM(DU), Mullana, Haryana

Locations

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Pediatric surgery ward, Maharishi Markandeshwar Hospital, Mullana

Ambāla, Haryana, India

Site Status

Countries

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India

References

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Boden I, Skinner EH, Browning L, Reeve J, Anderson L, Hill C, Robertson IK, Story D, Denehy L. Preoperative physiotherapy for the prevention of respiratory complications after upper abdominal surgery: pragmatic, double blinded, multicentre randomised controlled trial. BMJ. 2018 Jan 24;360:j5916. doi: 10.1136/bmj.j5916.

Reference Type BACKGROUND
PMID: 29367198 (View on PubMed)

Soares SM, Nucci LB, da Silva MM, Campacci TC. Pulmonary function and physical performance outcomes with preoperative physical therapy in upper abdominal surgery: a randomized controlled trial. Clin Rehabil. 2013 Jul;27(7):616-27. doi: 10.1177/0269215512471063. Epub 2013 Feb 12.

Reference Type BACKGROUND
PMID: 23405020 (View on PubMed)

Boden I, Browning L, Skinner EH, Reeve J, El-Ansary D, Robertson IK, Denehy L. The LIPPSMAck POP (Lung Infection Prevention Post Surgery - Major Abdominal - with Pre-Operative Physiotherapy) trial: study protocol for a multi-centre randomised controlled trial. Trials. 2015 Dec 15;16:573. doi: 10.1186/s13063-015-1090-6.

Reference Type BACKGROUND
PMID: 26666321 (View on PubMed)

Katsura M, Kuriyama A, Takeshima T, Fukuhara S, Furukawa TA. Preoperative inspiratory muscle training for postoperative pulmonary complications in adults undergoing cardiac and major abdominal surgery. Cochrane Database Syst Rev. 2015 Oct 5;2015(10):CD010356. doi: 10.1002/14651858.CD010356.pub2.

Reference Type BACKGROUND
PMID: 26436600 (View on PubMed)

Study Documents

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Document Type: Pilot study

Preserving pulmonary function and functional capacity in children undergoing open abdominal surgery: A one group pretest-posttest, quasiexperimental pilot trial

View Document

Document Type: Individual Participant Data Set

Effect of Pre-operative physiotherapy education and Post-operative physiotherapy in children with abdominal surgery", Mendeley Data, v1 http://dx.doi.org/10.17632/skkt9tsjd3.1

View Document

Document Type: Clinical Study Report

A randomized clinical trial in improving pulmonary function and functional capacity in paediatric open abdominal surgery

View Document

Related Links

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http://doi.org/10.1016/j.jpedsurg.2019.10.058

Preserving pulmonary function and functional capacity in children undergoing open abdominal surgery: A one group pretest-posttest, quasiexperimental pilot trial

Other Identifiers

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U1111-1213-2267

Identifier Type: REGISTRY

Identifier Source: secondary_id

L-79385/2018

Identifier Type: OTHER

Identifier Source: secondary_id

MMDU/IEC/1189

Identifier Type: -

Identifier Source: org_study_id

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