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

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

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.

Study Overview

• Status: Completed
• Conditions: Constipation
• Intervention / Treatment: Other: Transcutaneous Electrical Nerve Stimulator; Other: TENS on para sacral area with Abdominal Massage

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 44000
      • Jinnah Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group: A; TENS on sacral areas with Abdominal Massage	Other: Transcutaneous Electrical Nerve Stimulator; TENS will be applied on sacral and parasacral area. Frequency 10Hz, Pulse duration 200μs, Stimulation duration 20min
Active Comparator: Group: B; TENS on para sacral area with Abdominal Massage	Other: TENS on para sacral area with Abdominal Massage; TENS on para sacral area with Abdominal Massage. Frequency 10Hz Pulse duration 200μs Stimulation duration 20min

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Faiza Taufiq, PPDPT, Riphah International University, Senior Lecturer

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2023
• Primary Completion (Actual): March 15, 2024
• Study Completion (Actual): March 15, 2024

Study Registration Dates

• First Submitted: March 4, 2024
• First Submitted That Met QC Criteria: March 4, 2024
• First Posted (Actual): March 12, 2024

Study Record Updates

• Last Update Posted (Actual): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Constipation; Quality of life; Abdominal massage
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: S22C14G92003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No