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TENS modalities in the relief of menstrual cramps in young women

High and low frequency TENS in young people with primary dysmenorrhea: a randomized clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-10n3h7vz
Enrollment
Unknown
Registered
2023-07-31
Start date
2023-01-10
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Menstruation disturbances

Interventions

Eligible participants with pain equal to or greater than three on the Numeric Rating Scale (NRS) will be invited for randomization and inclusion in the intervention groups (Sample 150 participants - H
pulse frequency (Hz) – high frequency - 100Hz
pulse duration (microseconds - µs) - 100µs
current intensity (milliampere – mA): highest tolerable intensity, evaluated every five minutes, with continuous adjustment of current amplitude so that an intense sensation is felt throughout the tre
pulse frequency (Hz) - low frequency – 4Hz
E02.331.800

Sponsors

Universidade de Pernambuco
Lead Sponsor
Universidade de Pernambuco
Collaborator

Eligibility

Sex/Gender
Female
Age
15 Years to 29 Years

Inclusion criteria

Inclusion criteria: Young women; age between 15 and 29 years; nulliparous; regular menstrual cycle; self-report and presence of PD (pelvic or lower abdominal pain, occurring from 48 hours before the start of the menstrual period to 72 hours after the first day of menstruation); and with pain intensity greater than or equal to three points on the Numerical Rating Scale (NRS) during their participation

Exclusion criteria

Exclusion criteria: Pregnant women or mothers who are breastfeeding; use of any type of intrauterine device; skin lesions in the area where the electrodes will be placed; self-reported neurological or cardiac diseases; diagnosis of gynecological disorders (endometriosis, adenomyosis, uterine fibroids, etc.), which may be associated with secondary dysmenorrhea

Design outcomes

Primary

MeasureTime frame
Evaluate pain intensity relief using the Numerical Rating Scale (NRS), which is a tool to assess pain intensity, ranging from an 11-point scale, with scores of 0 = absence of pain and 10 = the worst pain imaginable. The scale will be filled before the intervention and immediately after intervention. A two-point modification is expected in the NRS, which can be considered a real change in pain intensity relief.

Secondary

MeasureTime frame
Evaluate the effect of analgesia in the 30 minutes, 1, 2, 4, 6, 8 and 12 and 24 hours after treatment, using the Numerical Rating Scale (NRS), which is a tool to evaluate pain intensity, ranging from a scale of 11 points, with scores of 0 = absence of pain and 10 = the worst pain imaginable. We will observe the effect of analgesia over the course of 24 hours.;Evaluate the volunteer's perception of satisfaction with the intervention after 24 hours, using a Likert scale, with a score from 1 to 5, being: (1) not at all effective; (2) somewhat effective; (3) moderately effective; (4) effective (5) very effective, which will have the objective of classifying and marking the answer that most reflects your degree of agreement with the statements presented: “TENS was effective in relieving menstrual pain” and “I am satisfied with the intervention for menstrual pain relief. ;Assessing the presence of adverse effects after 24 hours of the intervention will be recorded in the volunteer's medical records.;Evaluating the amount of medication intake after 24 hours of the intervention will be recorded in the volunteer's medical record.;Evaluate the level of physical activity of the volunteers, using the International Physical Activity Questionnaire (IPAQ) – short version. It is thought that the level of physical activity of the volunteers may interfere with the results of the main outcome.;Evaluate the interference of primary dysmenorrhea symptoms in women's physical, mental and social activities, using the Dysmenorrhea Symptom Interference Scale (DSI), which is a self-administered tool, with nine items, with response options: None (1); A little (2); Moderately (3); Enough (4); and Excessively (5), averaging individual item scores, which can be used if at least five of the nine items were answered, higher scores indicate greater interference (more negative outcome).;Evaluate the subjective aspects of pain, using the McGill Shortform Pain questionnaire, which consists of an abbrev

Countries

Brazil

Contacts

Public ContactAuxiliadora Renê Amaral

Universidade de Pernambuco

rene.amaral@upe.br+55 087 98843 7111

Outcome results

None listed

Source: REBEC (via WHO ICTRP)