The Use of Photobiomodulation for Pain and Healing in Cesarean Section: A Randomized, Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Pain Intensity
研究概览
简要总结
Good incisional wound healing and postoperative pain are the primary concerns regarding cesarean delivery, as it can lead to serious complications and delayed recovery for patients. Both pharmacological and non-pharmacological interventions have been investigated to promote effective analgesia and favorable healing of the cesarean surgical incision. Among the therapies under investigation for this purpose, photobiomodulation (PBM) stands out. Photobiomodulation consists of the use of low-intensity therapeutic light, and several publications have emphasized its analgesic properties and its capacity to promote wound healing across various etiologies. This study aims to evaluate the analgesic and wound-healing effects of PBM on the skin surgical incision following cesarean section. This will be a randomized controlled clinical trial in which 30 women undergoing elective cesarean delivery will be randomly allocated into two groups: a control group or a photobiomodulation group. All participants will receive standard hospital treatment for analgesia and postoperative wound care, combined with an active PBM protocol consisting of 3 J per point (658 nm) applied to the incisional area and 4.5 J per point (830 nm) applied around the wound, delivered immediately postoperatively, as well as 24 and 48 hours after surgery. The control group will undergo PBM with the laser device turned off, using the same protocol. Patients will be assessed before and after each PBM session, at 24 and 48 hours, and at 5, 10, and 40 days postpartum, to evaluate pain intensity using the Visual Analog Scale (VAS) and the McGill Pain Questionnaire, as well as wound healing using the REEDA scale. Clinical wound characteristics, epidemiological data, analgesic consumption during the inpatient period, and the occurrence of adverse events will be used as secondary outcomes. A two-way repeated-measures ANOVA will be used for comparisons between groups and across time points.
详细描述
Good incisional wound healing and postoperative pain are the primary concerns regarding cesarean delivery, as it can lead to serious complications and delayed recovery for patients. Both pharmacological and non-pharmacological interventions have been investigated to promote effective analgesia and favorable healing of the cesarean surgical incision. Among the therapies under investigation for this purpose, photobiomodulation (PBM) stands out. Photobiomodulation consists of the use of low-intensity therapeutic light, and several publications have emphasized its analgesic properties and its capacity to promote wound healing across various etiologies. This study aims to evaluate the analgesic and wound-healing effects of PBM on the skin surgical incision following cesarean section. This will be a randomized controlled clinical trial in which 30 women undergoing elective cesarean delivery will be randomly allocated into two groups: a control group or a photobiomodulation group. All participants will receive standard hospital treatment for analgesia and postoperative wound care, combined with an active PBM protocol consisting of 3 J per point (658 nm) applied to the incisional area and 4.5 J per point (830 nm) applied around the wound, delivered immediately postoperatively, as well as 24 and 48 hours after surgery. The control group will undergo PBM with the laser device turned off, using the same protocol. Patients will be assessed before and after each PBM session, at 24 and 48 hours, and at 5, 10, and 40 days postpartum, to evaluate pain intensity using the Visual Analog Scale (VAS) and the McGill Pain Questionnaire, as well as wound healing using the REEDA scale. Clinical wound characteristics, epidemiological data, analgesic consumption during the inpatient period, and the occurrence of adverse events will be used as secondary outcomes. A two-way repeated-measures ANOVA will be used for comparisons between groups and across time points. We also foresee a pilot interim analysis when recruitment reaches a size of 10 participants per group. This interim analysis will be performed using a two-way/means ANOVA to assess effect size and recalculate sample size, making adjustments to the design if necessary.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women undergoing cesarean section, regardless of whether indicated during labor or electively by maternal request;
- •Under follow-up at the Mandaqui Hospital Complex "Bispa Keila Campos Costa Ferreira" by the local Obstetrics team;
- •Admitted to the Hospital for delivery (either by referral or spontaneous demand) with adequate prenatal care (minimum of 7 visits);
- •Aged between 18 and 45 years;
- •Have undergone adequate prenatal follow-up;
- •Have a mobile phone with internet access and a video-calling application.
排除标准
- •Women with multiple gestation;
- •Women with uncontrolled systemic diseases;
- •Women with active infectious conditions as an indication for pregnancy resolution (e.g., patients with chorioamnionitis);
- •Women with a prior diagnosis of coagulation disorders;
- •Women with grade 3 obesity (BMI ≥ 40 kg/m²);
- •Women with photosensitivity;
- •Women with more than 2 previous cesarean sections (repeated/recurrent cesareans).
- •Women who, at the time of delivery, did not receive intraoperative prophylactic antibiotic therapy, who present secondary skin lesions from recent local shaving/trichotomy, or who were not submitted to preoperative surgical site degerming/preparation (all of which are measures that impact the reduction of surgical site infection risk);
- •Parturients who presented clinical complications during the immediate pre-hospital, intra-hospital, or intrapartum period.
研究组 & 干预措施
Treatment Group
Treatment Group - application of Photobiomodulation (PBM) therapy to the abdominal skin scar from the cesarean section, in addition to the standard hospital management treatment according to the institution's protocol.
干预措施: Photobiomodulation (PBM) (Radiation)
Treatment Group
Treatment Group - application of Photobiomodulation (PBM) therapy to the abdominal skin scar from the cesarean section, in addition to the standard hospital management treatment according to the institution's protocol.
干预措施: Standard Hospital Treatment (Other)
Controlled Group
Controlled Group - application of placebo Photobiomodulation (PBM) therapy to the abdominal skin scar from the cesarean section, in addition to the standard hospital management treatment according to the institution's protocol.
干预措施: Placebo PBM (Radiation)
Controlled Group
Controlled Group - application of placebo Photobiomodulation (PBM) therapy to the abdominal skin scar from the cesarean section, in addition to the standard hospital management treatment according to the institution's protocol.
干预措施: Standard Hospital Treatment (Other)
结局指标
主要结局
Pain Intensity
时间窗: Baseline" or "Day 1" , immediately after cesarean, immediately before and PBM session on 24 and 48 hours after cesarean, and 05, 10 and 40 days after cesarean
The presence of pain in the cutaneous reference region of the cesarean wound will be assessed using a Numerical Pain Scale (NPS) / The NPS is an aid in measuring the intensity of pain felt by the patient, an important instrument to verify progress and analyze the treatment instituted. The participant should be asked about their level of pain, where 0 means total absence of pain and 10 the maximum pain level.
Intensity Pain
时间窗: Time Frame: Baseline" or "Day 1" , immediately after cesarean, 24 and 48 hours after cesarean, and 05, 10 and 40 days after cesarean
The presence of pain in the cutaneous reference region of the cesarean wound will be assessed using a McGill Pain Questionnaire (Brazilian Portuguese validated version).
Cesarean Wound Healing
时间窗: 24 and 48 hours after cesarean, and 05, 10 and 40 days after cesarean
Edema and local wound healing will be assessed using the REEDA scale (Hill, 1990), which evaluates the inflammatory process and tissue repair following perineal trauma. Five healing parameters are assessed: redness, edema, ecchymosis, discharge, and approximation of wound edges (coaptation). Each item is scored from 0 to 3 by the evaluating clinician, with a maximum total score of 15 points indicating the poorest wound healing.
次要结局
- Amount of analgesic medications used (dosage, mg, and regimen)(Immediately after cesarean, 24 and 48 hours after cesarean, and 5, 10, and 40 days post-procedure,)
- Occurrence of postoperative complications(Baseline" or "Day 1" , immediately after cesarean, 24 and 48 hours after cesarean, and 05, 10 and 40 days after cesarean)
- Functionality(5, 10, and 40 days post-procedure)
- Adverse effects(immediately postoperatively, as well as 24 and 48 hours after surgery.)
研究者
Rebeca Boltes Cecatto
Professor M.D. Ph.D. Rebeca Boltes Cecatto
University of Nove de Julho