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Turkish Validation of The Drooling Impact Scale

Reliability and Construct Validity of the Turkish Version of the Drooling Impact Scale Among Children With Cerebral Palsy

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04132765
Enrollment
30
Registered
2019-10-21
Start date
2019-11-25
Completion date
2020-08-30
Last updated
2019-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy, Hypersalivation

Keywords

cerebral palsy, drooling impact scale, hypersalivation, validity

Brief summary

The aim of this study is to investigate the reliability and construct validity of the Turkish version of the Drooling Impact Scale in children with cerebral palsy

Detailed description

Drooling is common among several neurologic disorders such as cerebral palsy, Parkinson's disease, amyotrophic lateral sclerosis, which are the main diseases that physiatrist are one of the leading physicians involved in whose management 1. Drooling can be seen either as anterior drooling, unintentional leaving of saliva from mouth to outside of the body, or posterior drooling, invisible spill of saliva from mouth through pharyngeal isthmus and then to respiratory or digestive tract, inside the body 2. Anterior drooling causes psycho-social impairment, skin problems, infections, bad odor, dehydration, dentation problems and wet clothes and tools while posterior drooling may result in morbidity by posing a risk for aspiration pneumonia. Despite the frequency and significance of the condition, there is still a paucity of research and inadequate evidence about the various treatments and valid and reliable outcomes available. A major problem for research into interventions to reduce drooling is that there is no valid and reliable measurement tool of saliva control. There is no questionnaire in Turkish to evaluate the effects of drooling as well as drooling interventions.The aim of this study is to investigate the reliability and construct validity of the Turkish version of the Drooling Impact Scale in children with cerebral palsy.

Interventions

OTHERDrooling Impact Scale

A scale with 10 items which are scored with visual analog scale from1 to 10. Drooling impact increases with increased scores.

OTHERDrooling Frequency and Severity Scale

In this scale, parents or care givers were asked to rate the severity and frequency of drooling, classifying severity of drooling using a 5-level domain ranging from 1 (dry) to 5 (profuse drooling). The frequency of drooling was classified using a 4-level domain ranging from 1(no drooling) to 4 (constant drooling)

OTHERThe Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD™)

A quality of life scale that measure caregivers' perspectives on the health status, comfort, well being, and ease of caregiving of children with severe developmental disabilities. CPCHILD consists of 36 items distributed over six sections representing the following domains: (1) Personal Care (eight items); (2) Positioning, Transfer, and Mobility (eight items); (3) Communication and Social Interaction (seven items); (4) Comfort, Emotions, and Behaviour (nine items); (5) Health (three items); and (6) Overall Quality Of Life (one item). For the sections which involve the performance of skills, the degree of difficulty of accomplishing each task or activity was rated on a 7-point ordinal scale anchored by 0 ('No problem at all') to 6 ('Impossible').

OTHERDrooling Quotient (DQ)

DQ is a semi-quantitative method that assesses the presence of newly formed saliva on the lips every 15 seconds with 40 observations in 10 minutes, expressed as a percentage based on the ratio between the number of observed drooling episodes and the total number of observations.

OTHERPatient and caregiver visual analog scale (VAS) for drooling

Patients will be asked to score their children's drooling severity on a visual analog scale (0-100 mm, 0 none to 100 severe)

OTHERFunctional Oral Intake Scale (FOIS)

Functional Oral Intake Scale (FOIS) which is a 7-point ordinal scale document the functional level of oral intake of food and liquid.

OTHERnumber of bibs daily used

Parents will be asked their children's number of bibs daily used.

OTHERnumber of hospital admissions per year related to respiratory infections

Parents will be asked their children's number of hospital admissions per year related to respiratory infections.

The GMFCS describes self-initiated movement and use of assistive devices (walkers, crutches, canes, wheelchairs) for mobility during an individual's usual activity.

The MACS is also a simple, five-point ordinal classification system and was designed for use in children ages 4-18 years. The MACS is a validated measure in cerebral palsy that can be used to classify a child's typical use of both hands and upper limbs.

OTHERCommunication Function Classification System (CFCS)

The CFCS is a simple, five-point ordinal classification system that assesses everyday communication (not optimal communication) of children with cerebral palsy.

OTHEREating and Drinking Ability Classification System (EDACS)

EDACS is a measure to assess eating and drinking ability for children with CP, ages 3 and older. This classification is a simple five-point ordinal system.

Sponsors

Marmara University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
4 Years to 16 Years
Healthy volunteers
No

Inclusion criteria

1. Patients with unilateral or bilateral cerebral palsy at between the ages of 4-16 2. Spastic, dyskinetic or mixed type cerebral palsy 3. GMFCS level 3,4,5 4. Stable drooling within at least one month

Exclusion criteria

1. Active infection of salivary glands 2. Upper respiratory tract infection at the time of testing 3. History of anticholinergic drug intake in the past three weeks 4. Occurance of any above between test and re-test assessment that may interfere with the results

Design outcomes

Primary

MeasureTime frameDescription
Drooling Impact ScaleDay 0A scale with 10 items which are scored with visual analog scale from1 to 10. Drooling impact increases with increased scores.

Secondary

MeasureTime frameDescription
The Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD™)Day 0A quality of life scale that measure caregivers' perspectives on the health status, comfort, well being, and ease of caregiving of children with severe developmental disabilities. CPCHILD consists of 36 items distributed over six sections representing the following domains: (1) Personal Care (eight items); (2) Positioning, Transfer, and Mobility (eight items); (3) Communication and Social Interaction (seven items); (4) Comfort, Emotions, and Behaviour (nine items); (5) Health (three items); and (6) Overall Quality Of Life (one item). For the sections which involve the performance of skills, the degree of difficulty of accomplishing each task or activity was rated on a 7-point ordinal scale anchored by 0 ('No problem at all') to 6 ('Impossible').
Drooling Quotient (DQ)Day 0DQ is a semi-quantitative method that assesses the presence of newly formed saliva on the lips every 15 seconds with 40 observations in 10 minutes, expressed as a percentage based on the ratio between the number of observed drooling episodes and the total number of observations.
Patient and caregiver visual analog scale (VAS) for droolingDay 0Patients will be asked to score their children's drooling severity on a visual analog scale.
Functional Oral Intake Scale (FOIS)Day 0Functional Oral Intake Scale (FOIS) which is a 7-point ordinal scale document the functional level of oral intake of food and liquid.
number of bibs daily usedDay 0Parents will be asked their children's number of bibs daily used.
Drooling Frequency and Severity ScaleDay 0n this scale, parents or care givers were asked to rate the severity and frequency of drooling, classifying severity of drooling using a 5-level domain ranging from 1 (dry) to 5 (profuse drooling). The frequency of drooling was classified using a 4-level domain ranging from 1(no drooling) to 4 (constant drooling)
Gross Motor Function Classification System (GMFCS)Day 0The GMFCS describes self-initiated movement and use of assistive devices (walkers, crutches, canes, wheelchairs) for mobility during an individual's usual activity.
Manual Ability Classification System (MACS)Day 0The MACS is also a simple, five-point ordinal classification system and was designed for use in children ages 4-18 years. The MACS is a validated measure in cerebral palsy that can be used to classify a child's typical use of both hands and upper limbs.
Communication Function Classification System (CFCS)Day 0The CFCS is a simple, five-point ordinal classification system that assesses everyday communication (not optimal communication) of children with cerebral palsy.
Eating and Drinking Ability Classification System (EDACS)Day 0EDACS is a measure to assess eating and drinking ability for children with CP, ages 3 and older. This classification is a simple five-point ordinal system.
number of hospital admissions per year related to respiratory infectionsDay 0Parents will be asked their children's number of hospital admissions per year related to respiratory infections.

Countries

Turkey (Türkiye)

Contacts

Primary ContactEsra Giray, MD
girayesra@hotmail.com+905558134394
Backup ContactEvrim Karadag-Saygi, Prof
evrimkaradag4@hotmail.com+902166570606162

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026