Abdominal Massage With TENS on Parasacral Versus Sacral Area on Symptom,Severity & QOL in Chronic Constipation Females.

Constipation Clinical Trial

Official title:

Effects of Abdominal Massage With TENS on Para Sacral Versus Sacral Area on Symptom Severity and Quality of Life in Severe Chronic Constipation Among Young Females

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06303011
• Other study ID #: S22C14G92003
• Status: Completed
• Phase: N/A
• Start date: March 15, 2023
• Est. completion date: March 15, 2024

Study information

• Verified date: April 2024
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Constipation is Infrequent or difficult evacuation of FECES. These symptoms are associated with a variety of causes, including low DIETARY FIBER intake, emotional or nervous disturbances, systemic and structural disorders, drug-induced aggravation, and infections. Patients complaining of constipation may mean different things by the term The frequency of their bowel actions may be less than 'normal', their stools maybe difficult to pass, or they may have a sense of malaise or abdominal discomfort which they attribute to a 'sluggish bowel', though the stool frequency and consistency are apparently normal. Objective of this study is to compare effects of Abdominal massage. withTENSonparasacralversussacralareaonsymptomseverityandqualityoflifein severechronicconstipationamongyoungfemales.

Description:

This study will be a Randomized Clinical trial and will be conducted at services Hospital in Lahore. The study will be completed with in the time duration of eight months. Purposive sampling technique will be used to collect the data. A sample size of Total 24 patients will be taken in this study. Patients will be divided into two groups.(Group A will be treated with TENS on sacral area and abdominal massage where as Group B will be treated with TENS on par sacral area and abdominal massage).PAC-SYM Questionaire,PAC-QOL Questionaire will be used to ask some questions related to patients 'symptoms and abdominal cramps or bloating.. All participants of the study will fill the PAC-SYMQ and PAC-QOL Q on day 1 as pre treatment values and at the end of 4th session as post treatment values respectively. The collected data will be analyzed on SPSS-25.

Keywords : constipation, Quality of life , abdominal massage.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: March 15, 2024
• Est. primary completion date: March 15, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 14 Years to 35 Years

Eligibility

Inclusion Criteria:

• Age between 14 -35year

• Only females

• Laxatives at least once or more for 2weeks

• Non pregnant

• Chronic Constipation more then 6 months

Exclusion Criteria:

• Organic dysphasia or secondary constipation caused by laxatives for unrelated conditions.

• Pregnant females suspected pregnant subjects, as well as those who were breast-feeding

• Non co-operative patients

• Female with underlying disease

Related Conditions & MeSH terms

• Constipation

Intervention

Other:
• Transcutaneous Electrical Nerve Stimulator
TENS will be applied on sacral and parasacral area. Frequency 10Hz, Pulse duration 200µs, Stimulation duration 20min
• TENS on para sacral area with Abdominal Massage
TENS on para sacral area with Abdominal Massage. Frequency 10Hz Pulse duration 200µs Stimulation duration 20min

Locations

Country	Name	City	State
Pakistan	Jinnah Hospital	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PAC-SYM Questionnaire	It is a self-reported questionnaire consisting of 12 symptoms divided into three domains: abdominal, rectal and stool, with responses rated on a. 5-point.The Patient Assessment of Constipation-Symptoms (PAC-SYM) questionnaire is frequently used in clinical trials of constipation. However, the threshold for reduction in total PAC-SYM score used to define a clinical response on this 0-4 point scale has not undergone formal appraisal, and its relationship with clinical benefit as perceived by patients has not been defined.; PAC-SYM Questionnaire Validity is 0.68 to 0.72 and reliability is 0.75to 0.89	8 weeks
Primary	PAC-QOL Questionnaire	The following questions are designed to measure the impact constipation has had on your daily life over the past 2 weeks. The overall PAC-QOL score consisted of four domains: physical discomfort, psycho- social discomfort, satisfaction, and worries and concerns. A lower score indicated a better outcome for symptomatic relief and QOL. PAC-QOL Questionnaire Validity is 0.76 to 3.41 and reliability is >0.80.	8 weeks