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OpenTrials
Completed

NCT Number: NCT06303011

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

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Key information

Conditions

Constipation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

14 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Jinnah Hospital

Lahore, Punjab Province, 44000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcutaneous Electrical Nerve Stimulator

Other

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

Other

TENS on para sacral area with Abdominal Massage. Frequency 10Hz Pulse duration 200μs Stimulation duration 20min

Primary outcomes

  1. PAC-SYM Questionnaire

    Time frame: 8 weeks

    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

  2. PAC-QOL Questionnaire

    Time frame: 8 weeks

    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.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 12, 2024
Registry last updated
Apr 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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