Functional ConstipationNCT06353841
Effect of Therapeutic Touch on Functional Constipation in Infants and Young Children
A study testing Therapeutic Touch in people with Functional Constipation and Therapeutic Touch, run by Burdur Mehmet Akif Ersoy University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to determine the effect of therapeutic touch on functional constipation in infants and young children. Read more about this study
- Who is it for?
- Ages 6 to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Functional Constipation, Therapeutic Touch, Infants
- What is being tested?
- Therapeutic Touch
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 May 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 24 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The infant is between 6-24 months,
- The infant was born at term,
- Birth weight between 2500-4500 g,
- Must have been diagnosed with functional constipation by the physician according to ROMA IV criteria,
- Mothers' ability to read, write and speak Turkish,
- Parent's willingness to participate in the research.
Who cannot join
- The infant has a congenital anomaly,
- The infant has any chronic disease,
- Having a secondary disease that causes constipation such as cow's milk allergy, celiac disease, hypercalcemia and hypothyroidism, neurological diseases,Children with any organic or metabolic diseases
- The parent has a verbal and written communication barrier.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Burdur Bucak State Hospital
Burdur, Bucak, 15030
About this study
Official title: The Effect of Therapeutic Touch on Functional Constipation in Infants and Young Children: A Randomized Controlled Study
The aim of the study is to determine the effect of therapeutic touch on functional constipation in infants and young children.
Read the detailed description
Functional constipation (FK) is a common functional gastrointestinal disorder that affects children's quality of life. The reported prevalence of functional constipation in infants and young children varies according to diagnostic criteria between studies. Laxatives and probiotics are commonly used to treat functional constipation. Therefore, treating constipation is very costly and there is not enough reliable data on this subject. When the literature is examined, the use of non-pharmacological methods to reduce, prevent and eliminate constipation has been increasing recently. When the studies were examined, studies using different methods were found. The main methods used in the care of children with constipation are; massage, aromatherapy, probiotics, laxatives, reflexology and acupuncture. The effect of therapeutic touch is thought to have positive results, especially in newborns, infants and children.Based on the studies conducted in line with the literature, this research has a randomized controlled experimental design to determine the effect of therapeutic touch applied to infants and children diagnosed with functional constipation according to Rome IV criteria on constipation.
This study is a prospective, randomized and controlled trial. The study population consisted of infants and children aged 6 to 24 months. Sample of the study consisted of a total of 60 children who met the sample selection criteria and were selected via randomization method. Children were randomized into two groups: intervention gorup (n=30) and control group (n=30). Data were collected using the Interview and Observation Form, Primary Results Follow-up Form, and Bristol stool form scale.
- Conditions
- Functional Constipation, Therapeutic Touch, Infants, Children, Constipation
- Being tested
- Therapeutic Touch
- Keywords
- Therapeutic Touch, Functional Constipation, Infants, Children
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic TouchBehavioural
Therapeutic Touch will be applied to infants for 3 consecutive days, once a day, 10 minutes at any time during the day. There will be a four-day break. The Therapeutic Touch will be done a total of 3 times a week in four weeks.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Therapeutic Touch will be applied to infants for three consecutive days, once a day, ten minutes at any time during the day. There will be a four-day break. The Therapeutic Touch will be done a total of three times in one week. Receives: Behavioral: Therapeutic Touch |
| Control group | No intervention | The therapeutic touch will not be applied to the control group infants. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Results Follow-up Form
Weekly Bowel sounds (movements) (min)
Measured: In four weeks
Primary Results Follow-up Form
Number of stools
Measured: In four weeks
Primary Results Follow-up Form
Stool density
Measured: In four weeks
Primary Results Follow-up Form
Weight (g)
Measured: In four weeks
Primary Results Follow-up Form
Abdominal circumference (cm)
Measured: In four weeks
Secondary outcomes (2)
Bristol Stool Scale
In this scoring system, stool hardness is evaluated from the hardest to the softest, according to the adhesion and cracking characteristics of the stool.
In this scoring system, stool hardness is from the hardest to the softest, according to the adhesion and cracking characteristics of the stool; is divided into seven classes: hard scattered tubers like hazelnuts:Type 1, sausage-shaped but lumpy:Type 2, like a sausage but with cracks on the surface:Type 3, smooth and soft like a sausage or snake:Type 4, soft grains with obvious cuts on the edges:Type 5, mushy stool with irregular edges and fluid pieces:Type 6, watery, with no solid pieces, and completely liquid:Type 7. Type 1 and Type 2 are difficult defecation patterns and suggest the presence of constipation, Type 3, Type 4 and Type 5 indicate normal defecation, and Type 6 and Type 7 suggest diarrhea.
Measured: In four weeks
Constipation discomfort
Child's Distress Intensity: The child's discomfiture intensity during defecation will be defined. (0-3 points: "0" no crying or grimace, "1" mild crying and grimace, "2" moderate crying and grimace, "3" hysterical intense crying and grimace.) (Zhang et al., 2022).
Measured: In four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start3 May 2023
- Primary completion26 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Burdur Mehmet Akif Ersoy University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selda Ateş Beşirik, Burdur Mehmet Akif Ersoy University
- Investigators
- Selda Ateş Beşirik, PhD., Principal investigator, Burdur Mehmet Akif Ersoy UniversityEmine Geçkil, Professor, Study director, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06353841
- Sponsor's protocol ID
- 2023/435
- Status last verified
- Dec 2024
- First submitted
- 31 Mar 2024
- Last updated
- 1 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Therapeutic Touch on Functional Constipation in Infants and Young Children: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06353841
- Acronym / sponsor ID
- 2023/435
- Conditions
- Functional Constipation, Therapeutic Touch, Infants, Children, Constipation
- Keywords
- Therapeutic Touch, Functional Constipation, Infants, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Burdur Mehmet Akif Ersoy UniversityUniversity, hospital or other
- Study start
- 3 May 2023 (actual)
- Primary completion
- 26 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 9 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to determine the effect of therapeutic touch on functional constipation in infants and young children.
Detailed description
Functional constipation (FK) is a common functional gastrointestinal disorder that affects children's quality of life. The reported prevalence of functional constipation in infants and young children varies according to diagnostic criteria between studies. Laxatives and probiotics are commonly used to treat functional constipation. Therefore, treating constipation is very costly and there is not enough reliable data on this subject. When the literature is examined, the use of non-pharmacological methods to reduce, prevent and eliminate constipation has been increasing recently. When the studies were examined, studies using different methods were found. The main methods used in the care of children with constipation are; massage, aromatherapy, probiotics, laxatives, reflexology and acupuncture. The effect of therapeutic touch is thought to have positive results, especially in newborns, infants and children.Based on the studies conducted in line with the literature, this research has a randomized controlled experimental design to determine the effect of therapeutic touch applied to infants and children diagnosed with functional constipation according to Rome IV criteria on constipation.
This study is a prospective, randomized and controlled trial. The study population consisted of infants and children aged 6 to 24 months. Sample of the study consisted of a total of 60 children who met the sample selection criteria and were selected via randomization method. Children were randomized into two groups: intervention gorup (n=30) and control group (n=30). Data were collected using the Interview and Observation Form, Primary Results Follow-up Form, and Bristol stool form scale.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Therapeutic TouchTherapeutic Touch will be applied to infants for three consecutive days, once a day, ten minutes at any time during the day. There will be a four-day break. The Therapeutic Touch will be done a total of three times in one week. |
| Control group | No intervention | –The therapeutic touch will not be applied to the control group infants. |
Who may qualify
- Ages
- 6 to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- The infant is between 6-24 months,
- The infant was born at term,
- Birth weight between 2500-4500 g,
- Must have been diagnosed with functional constipation by the physician according to ROMA IV criteria,
- Mothers' ability to read, write and speak Turkish,
Key exclusion criteria (4 listed)
- The infant has a congenital anomaly,
- The infant has any chronic disease,
- Having a secondary disease that causes constipation such as cow's milk allergy, celiac disease, hypercalcemia and hypothyroidism, neurological diseases,Children with any organic or metabolic diseases
- The parent has a verbal and written communication barrier.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic TouchTherapeutic Touch will be applied to infants for 3 consecutive days, once a day, 10 minutes at any time during the day. There will be a four-day break. The Therapeutic Touch will be done a total of 3 times a week in four weeks. | Behavioural | Intervention Group |
Primary outcome
Primary Results Follow-up Form
Time frame: In four weeks
Weekly Bowel sounds (movements) (min)
Primary Results Follow-up Form
Time frame: In four weeks
Number of stools
Primary Results Follow-up Form
Time frame: In four weeks
Stool density
Primary Results Follow-up Form
Time frame: In four weeks
Weight (g)
Primary Results Follow-up Form
Time frame: In four weeks
Abdominal circumference (cm)
2 secondary outcomes
Bristol Stool Scale
Time frame: In four weeks
Constipation discomfort
Time frame: In four weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2025.
Related trials for Functional Constipation
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
Active, not recruitingPhase 2
This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
Not yet recruitingPhase 3
Rifaximin Treatment in Bloating Predominant Functional Bowel Disorders
Bloating, Rifaximin
Recruiting
Effects of Connective Tissue Massage Plus Biofeedback for Dyssynergic Defecation
Dyssynergic Defecation
RecruitingObservational study
Relationship Between Interoception and Postural Control in Constipation-Predominant Irritable Bowel Syndrome
Constipation, Irritable Bowel Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Selda Ateş Beşirik, PhD. principal investigator
Burdur Mehmet Akif Ersoy University
Emine Geçkil, Professor study director
Necmettin Erbakan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Touch in people with Functional Constipation and Therapeutic Touch, run by Burdur Mehmet Akif Ersoy University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Results Follow-up Form (time frame: In four weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jan 2025.